English and Latin Index 7th Edition 70

EUROPEAN PHARMACOPOEIA 7.0

INDEXMonographs deleted from the 6th Edition are not included in the index; a list of deleted texts is found in the Contents ofVolume 1, page xxii.

English index ........................................................................ 3267 Latin index ................................................................................. 3295

General Notices (1) apply to all monographs and other texts 3265

EUROPEAN PHARMACOPOEIA 7.0

3266 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 7.0 Index

Numerics1. General notices .................................................................................32.1.1. Droppers ................................................................................... 152.1.2. Comparative table of porosity of sintered-glass filters ... 152.1.3. Ultraviolet ray lamps for analytical purposes................... 152.1.4. Sieves .........................................................................................162.1.5. Tubes for comparative tests ..................................................172.1.6. Gas detector tubes...................................................................172.1. Apparatus .................................................................................... 152.2.10. Viscosity - Rotating viscometer method.......................... 282.2.11. Distillation range .................................................................. 302.2.12. Boiling point ..........................................................................312.2.13. Determination of water by distillation..............................312.2.14. Melting point - capillary method........................................312.2.15. Melting point - open capillary method ............................ 322.2.16. Melting point - instantaneous method ............................ 322.2.17. Drop point .............................................................................. 322.2.18. Freezing point....................................................................... 342.2.19. Amperometric titration ....................................................... 342.2.1. Clarity and degree of opalescence of liquids.....................212.2.20. Potentiometric titration ...................................................... 342.2.21. Fluorimetry............................................................................ 352.2.22. Atomic emission spectrometry .......................................... 352.2.23. Atomic absorption spectrometry ...................................... 362.2.24. Absorption spectrophotometry, infrared ........................ 382.2.25. Absorption spectrophotometry, ultraviolet andvisible.................................................................................................. 40

2.2.26. Paper chromatography ........................................................412.2.27. Thin-layer chromatography ................................................ 422.2.28. Gas chromatography ........................................................... 432.2.29. Liquid chromatography ...................................................... 452.2.2. Degree of coloration of liquids............................................ 222.2.30. Size-exclusion chromatography ........................................ 462.2.31. Electrophoresis ..................................................................... 462.2.31. Electrophoresis (5.8.)......................................................... 6212.2.32. Loss on drying .......................................................................512.2.33. Nuclear magnetic resonance spectrometry .................... 522.2.34. Thermal analysis................................................................... 542.2.35. Osmolality .............................................................................. 572.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes............................. 57

2.2.37. X-ray fluorescence spectrometry....................................... 582.2.38. Conductivity .......................................................................... 592.2.39. Molecular mass distribution in dextrans ........................ 602.2.3. Potentiometric determination of pH.................................. 242.2.40. Near-infrared spectrophotometry ......................................612.2.41. Circular dichroism................................................................ 652.2.42. Density of solids ................................................................... 662.2.43. Mass spectrometry ............................................................... 672.2.44. Total organic carbon in water for pharmaceuticaluse....................................................................................................... 69

2.2.45. Supercritical fluid chromatography................................. 702.2.46. Chromatographic separation techniques........................ 702.2.47. Capillary electrophoresis .................................................... 772.2.47. Capillary electrophoresis (5.8.)........................................ 6212.2.48. Raman spectrometry ........................................................... 822.2.49. Falling ball viscometer method......................................... 832.2.4. Relationship between reaction of solution, approximate pHand colour of certain indicators ................................................... 25

2.2.54. Isoelectric focusing.............................................................. 832.2.54. Isoelectric focusing (5.8.) ................................................. 6212.2.55. Peptide mapping................................................................... 852.2.55. Peptide mapping (5.8.) ...................................................... 6212.2.56. Amino acid analysis ............................................................. 882.2.56. Amino acid analysis (5.8.)................................................. 6212.2.57. Inductively coupled plasma-atomic emissionspectrometry ..................................................................................... 94

2.2.58. Inductively coupled plasma-mass spectrometry ............ 962.2.59. Glycan analysis of glycoproteins....................................... 972.2.5. Relative density....................................................................... 252.2.60. Melting point - instrumental method............................. 1022.2.6. Refractive index ...................................................................... 26

2.2.7. Optical rotation ....................................................................... 262.2.8. Viscosity.................................................................................... 272.2.9. Capillary viscometer method ............................................... 272.2. Physical and physicochemical methods.................................212.3.1. Identification reactions of ions and functional groups.. 1072.3.2. Identification of fatty oils by thin-layer chromato-graphy .............................................................................................. 110

2.3.3. Identification of phenothiazines by thin-layerchromatography............................................................................. 110

2.3.4. Odour ...................................................................................... 1102.3. Identification............................................................................. 1072.4.10. Lead in sugars......................................................................1172.4.11. Phosphates............................................................................1172.4.12. Potassium..............................................................................1172.4.13. Sulfates................................................................................. 1182.4.14. Sulfated ash......................................................................... 1182.4.14. Sulfated ash (5.8.) .............................................................. 6222.4.15. Nickel in polyols ................................................................. 1182.4.16. Total ash............................................................................... 1182.4.17. Aluminium............................................................................ 1182.4.18. Free formaldehyde ............................................................. 1182.4.19. Alkaline impurities in fatty oils ....................................... 1192.4.1. Ammonium............................................................................. 1132.4.21. Foreign oils in fatty oils by thin-layer chromato-graphy .............................................................................................. 119

2.4.22. Composition of fatty acids by gas chromatography ... 1192.4.23. Sterols in fatty oils ............................................................. 1212.4.24. Identification and control of residual solvents............ 1232.4.25. Ethylene oxide and dioxan............................................... 1272.4.26. N,N-Dimethylaniline .......................................................... 1282.4.27. Heavy metals in herbal drugs and fatty oils ................. 1292.4.28. 2-Ethylhexanoic acid ......................................................... 1302.4.29. Composition of fatty acids in oils rich in omega-3acids.................................................................................................. 130

2.4.2. Arsenic .................................................................................... 1132.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ....................................................................................... 132

2.4.31. Nickel in hydrogenated vegetable oils ........................... 1322.4.32. Total cholesterol in oils rich in omega-3 acids ............ 1332.4.3. Calcium................................................................................... 1132.4.4. Chlorides ................................................................................ 1132.4.5. Fluorides .................................................................................1142.4.6. Magnesium..............................................................................1142.4.7. Magnesium and alkaline-earth metals ..............................1142.4.8. Heavy metals ..........................................................................1142.4.9. Iron ...........................................................................................1172.4. Limit tests .................................................................................. 1132.5.10. Oxygen-flask method......................................................... 1392.5.11. Complexometric titrations................................................ 1402.5.12. Water : semi-micro determination ................................... 1402.5.13. Aluminium in adsorbed vaccines.....................................1412.5.14. Calcium in adsorbed vaccines ..........................................1412.5.15. Phenol in immunosera and vaccines ..............................1412.5.16. Protein in polysaccharide vaccines .................................1412.5.17. Nucleic acids in polysaccharide vaccines ...................... 1422.5.18. Phosphorus in polysaccharide vaccines........................ 1422.5.19. O-Acetyl in polysaccharide vaccines............................... 1422.5.1. Acid value............................................................................... 1372.5.20. Hexosamines in polysaccharide vaccines...................... 1422.5.21. Methylpentoses in polysaccharide vaccines ................. 1432.5.22. Uronic acids in polysaccharide vaccines ....................... 1432.5.23. Sialic acid in polysaccharide vaccines ........................... 1432.5.24. Carbon dioxide in gases.................................................... 1432.5.25. Carbon monoxide in gases............................................... 1442.5.26. Nitrogen monoxide and nitrogen dioxide in gases ..... 1452.5.27. Oxygen in gases .................................................................. 1452.5.28. Water in gases..................................................................... 1452.5.29. Sulfur dioxide ..................................................................... 1452.5.2. Ester value ............................................................................. 1372.5.30. Oxidising substances......................................................... 1462.5.31. Ribose in polysaccharide vaccines.................................. 1462.5.32. Water : micro determination ............................................ 1462.5.33. Total protein........................................................................ 147


Index EUROPEAN PHARMACOPOEIA 7.0

2.5.34. Acetic acid in synthetic peptides .................................... 1502.5.35. Nitrous oxide in gases ....................................................... 1502.5.36. Anisidine value ................................................................... 1502.5.3. Hydroxyl value ...................................................................... 1372.5.4. Iodine value ........................................................................... 1372.5.5. Peroxide value....................................................................... 1382.5.6. Saponification value ............................................................ 1392.5.7. Unsaponifiable matter ......................................................... 1392.5.8. Determination of primary aromatic amino-nitrogen .... 1392.5.9. Determination of nitrogen by sulfuric acid digestion .. 1392.5. Assays ......................................................................................... 1372.6.10. Histamine ............................................................................. 1622.6.11. Depressor substances........................................................ 1622.6.12. Microbiological examination of non-sterile products :microbial enumeration tests........................................................ 163

2.6.12. Microbiological examination of non-sterile products :microbial enumeration tests (5.8.) ............................................. 622

2.6.13. Microbiological examination of non-sterile products : testfor specified micro-organisms ..................................................... 167

2.6.13. Microbiological examination of non-sterile products : testfor specified micro-organisms (5.8.)........................................... 622

2.6.14. Bacterial endotoxins .......................................................... 1712.6.15. Prekallikrein activator....................................................... 1752.6.16. Tests for extraneous agents in viral vaccines for humanuse .................................................................................................... 176

2.6.17. Test for anticomplementary activity ofimmunoglobulin............................................................................. 177

2.6.18. Test for neurovirulence of live virus vaccines.............. 1792.6.19. Test for neurovirulence of poliomyelitis vaccine(oral) ................................................................................................. 179

2.6.1. Sterility ................................................................................... 1532.6.20. Anti-A and anti-B haemagglutinins (indirect meth-od) ..................................................................................................... 180

2.6.21. Nucleic acid amplification techniques ........................... 1812.6.22. Activated coagulation factors .......................................... 1852.6.24. Avian viral vaccines : tests for extraneous agents inseed lots ........................................................................................... 185

2.6.25. Avian live virus vaccines : tests for extraneous agents inbatches of finished product......................................................... 188

2.6.26. Test for anti-D antibodies in human immunoglobulin forintravenous administration ......................................................... 191

2.6.27. Microbiological control of cellular products ................ 1912.6.2. Mycobacteria ......................................................................... 1562.6.30. Monocyte-activation test ................................................... 1922.6.31. Microbiological examination of herbal medicinalproducts for oral use..................................................................... 197

2.6.7. Mycoplasmas.......................................................................... 1562.6.8. Pyrogens................................................................................. 1612.6.9. Abnormal toxicity ................................................................. 1622.6. Biological tests ......................................................................... 1532.7.10. Assay of human coagulation factor VII ......................... 2192.7.11. Assay of human coagulation factor IX ........................... 2192.7.12. Assay of heparin in coagulation factors ........................ 2202.7.13. Assay of human anti-D immunoglobulin....................... 2202.7.14. Assay of hepatitis A vaccine ............................................. 2222.7.15. Assay of hepatitis B vaccine (rDNA)............................... 2232.7.16. Assay of pertussis vaccine (acellular)............................. 2232.7.17. Assay of human antithrombin III .................................... 2242.7.18. Assay of human coagulation factor II ............................ 2242.7.19. Assay of human coagulation factor X ............................ 2252.7.19. Assay of human coagulation factor X (2.7.19.)............. 2252.7.1. Immunochemical methods ................................................. 2012.7.20. In vivo assay of poliomyelitis vaccine (inactivated).... 2252.7.21. Assay of human von Willebrand factor.......................... 2262.7.22. Assay of human coagulation factor XI........................... 2272.7.23. Numeration of CD34/CD45+ cells in haemato-poietic products ............................................................................. 228

2.7.24. Flow cytometry ................................................................... 2292.7.25. Assay of human plasmin inhibitor .................................. 2302.7.27. Flocculation value (Lf) of diphtheria and tetanus toxinsand toxoids (Ramon assay) .......................................................... 231

2.7.28. Colony-forming cell assay for human haematopoietic pro-genitor cells..................................................................................... 232

2.7.29. Nucleated cell count and viability................................... 2332.7.2. Microbiological assay of antibiotics .................................. 2022.7.30. Assay of human protein C ................................................ 2342.7.31. Assay of human protein S................................................. 2352.7.32. Assay of human α-1-proteinase inhibitor ...................... 2362.7.4. Assay of human coagulation factor VIII .......................... 2072.7.5. Assay of heparin.................................................................... 2082.7.6. Assay of diphtheria vaccine (adsorbed) ........................... 2092.7.7. Assay of pertussis vaccine................................................... 2132.7.8. Assay of tetanus vaccine (adsorbed)................................. 2142.7.9. Test for Fc function of immunoglobulin ..........................2172.7. Biological assays ...................................................................... 2012.8.10. Solubility in alcohol of essential oils ............................. 2402.8.11. Assay of 1,8-cineole in essential oils .............................. 2402.8.12. Determination of essential oils in herbal drugs .......... 2412.8.13. Pesticide residues............................................................... 2422.8.14. Determination of tannins in herbal drugs .................... 2432.8.15. Bitterness value .................................................................. 2442.8.16. Dry residue of extracts...................................................... 2442.8.17. Loss on drying of extracts ................................................ 2442.8.18. Determination of aflatoxin B1 in herbal drugs ............ 2442.8.1. Ash insoluble in hydrochloric acid ................................... 2392.8.20. Herbal drugs : sampling and sample preparation........ 2462.8.21. Test for aristolochic acids in herbal drugs ................... 2472.8.22. Determination of ochratoxin A in herbal drugs.......... 2492.8.23. Microscopic examination of herbal drugs .................... 2502.8.2. Foreign matter ...................................................................... 2392.8.3. Stomata and stomatal index .............................................. 2392.8.4. Swelling index....................................................................... 2392.8.5. Water in essential oils.......................................................... 2392.8.6. Foreign esters in essential oils .......................................... 2392.8.7. Fatty oils and resinified essential oils in essential oils .. 2392.8.8. Odour and taste of essential oils....................................... 2402.8.9. Residue on evaporation of essential oils ......................... 2402.8. Methods in pharmacognosy .................................................. 2392.9.10. Ethanol content and alcoholimetric tables .................. 2682.9.11. Test for methanol and 2-propanol .................................. 2702.9.12. Sieve test .............................................................................. 2702.9.14. Specific surface area by air permeability ...................... 2712.9.16. Flowability............................................................................ 2722.9.17. Test for extractable volume of parenteralpreparations .................................................................................... 273

2.9.17. Test for extractable volume of parenteral preparations(5.8.).................................................................................................. 622

2.9.18. Preparations for inhalation : aerodynamic assessment offine particles ................................................................................... 274

2.9.19. Particulate contamination : sub-visible particles ......... 2852.9.1. Disintegration of tablets and capsules............................. 2532.9.20. Particulate contamination: visible particles ................ 2872.9.22. Softening time determination of lipophilicsuppositories................................................................................... 288

2.9.23. Gas pycnometric density of solids .................................. 2882.9.25. Dissolution test for medicated chewing gums............. 2892.9.26. Specific surface area by gas adsorption........................ 2912.9.26. Specific surface area by gas adsorption (5.8.) ............. 6222.9.27. Uniformity of mass of delivered doses from multidosecontainers........................................................................................ 294

2.9.29. Intrinsic dissolution........................................................... 2942.9.2. Disintegration of suppositories and pessaries ............... 2552.9.31. Particle size analysis by laser light diffraction ............ 2952.9.32. Porosity and pore-size distribution of solids by mercuryporosimetry ..................................................................................... 299

2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD)............................... 301

2.9.34. Bulk density and tapped density of powders............... 3052.9.35. Powder fineness ................................................................. 3082.9.36. Powder flow......................................................................... 3082.9.36. Powder flow (5.8.) .............................................................. 6222.9.37. Optical microscopy..............................................................3112.9.37. Optical microscopy (5.8.) .................................................. 6222.9.38. Particle-size distribution estimation by analyticalsieving .............................................................................................. 313



2.9.38. Particle-size distribution estimation by analytical sieving(5.8.).................................................................................................. 623

2.9.3. Dissolution test for solid dosage forms ........................... 2562.9.40. Uniformity of dosage units............................................... 3152.9.41. Friability of granules and spheroids .............................. 3182.9.42. Dissolution test for lipophilic solid dosage forms....... 3192.9.43. Apparent dissolution ......................................................... 3202.9.45. Wettability of porous solids including powders .......... 3212.9.4. Dissolution test for transdermal patches ........................ 2632.9.5. Uniformity of mass of single-dose preparations............. 2652.9.6. Uniformity of content of single-dose preparations........ 2662.9.7. Friability of uncoated tablets ............................................. 2662.9.7. Friability of uncoated tablets (5.8.)................................... 6222.9.8. Resistance to crushing of tablets...................................... 2672.9.9. Measurement of consistency by penetrometry .............. 2672.9. Pharmaceutical technical procedures ................................. 2533.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions ............ 349

3.1.11. Materials based on non-plasticised poly(vinyl chloride) forcontainers for dry dosage forms for oral administration...... 350

3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components............. 329

3.1.1.2. Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents..................................................................................... 332

3.1.13. Plastic additives .................................................................. 3523.1.14. Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion ..355

3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use........................................... 357

3.1.1. Materials for containers for human blood and bloodcomponents..................................................................................... 329

3.1.3. Polyolefines............................................................................ 3343.1.4. Polyethylene without additives for containers forparenteral preparations and for ophthalmic preparations ...337

3.1.5. Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations ....................... 338

3.1.6. Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations.............................. 342

3.1.7. Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations..................................... 345

3.1.8. Silicone oil used as a lubricant ......................................... 3473.1.9. Silicone elastomer for closures and tubing .................... 3473.1. Materials used for the manufacture of containers ........... 3293.2.1. Glass containers for pharmaceutical use ........................ 3633.2.2.1. Plastic containers for aqueous solutions forinfusion ............................................................................................ 368

3.2.2. Plastic containers and closures for pharmaceuticaluse..................................................................................................... 368

3.2.3. Sterile plastic containers for human blood andblood components ......................................................................... 369

3.2.4. Empty sterile containers of plasticised poly(vinyl chloride)for human blood and blood components ................................. 370

3.2.5. Sterile containers of plasticised poly(vinyl chloride) forhuman blood containing anticoagulant solution ................... 371

3.2.6. Sets for the transfusion of blood and bloodcomponents..................................................................................... 371

3.2.8. Sterile single-use plastic syringes ..................................... 3733.2.9. Rubber closures for containers for aqueousparenteral preparations, for powders and forfreeze-dried powders ..................................................................... 374

3.2. Containers ................................................................................. 3634.1.1. Reagents ................................................................................. 3794.1.2. Standard solutions for limit tests...................................... 4854.1.3. Buffer solutions .................................................................... 4894.1. Reagents, standard solutions, buffer solutions ................. 3794.2.1. Primary standards for volumetric solutions................... 4944.2.2. Volumetric solutions............................................................ 4944.2. Volumetric analysis.................................................................. 4944-Aminobenzoic acid .....................................................................13714. Reagents........................................................................................ 3795.10. Control of impurities in substances for pharmaceuticaluse..................................................................................................... 631

5.1.10. Guidelines for using the test for bacterial endotoxins .. 5205.11. Characters section in monographs .................................... 6375.1.1. Methods of preparation of sterile products .................... 5035.1.2. Biological indicators of sterilisation................................. 5045.12. Reference standards.............................................................. 6415.1.3. Efficacy of antimicrobial preservation ............................. 5055.14. Gene transfer medicinal products for human use .......... 6475.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use ........... 507

5.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use (5.8.) .. 623

5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ................................................................... 508

5.15. Functionality-related characteristics of excipients......... 6615.1.6. Alternative methods for control of microbiologicalquality............................................................................................... 508

5.17.1. Recommendations on dissolution testing ..................... 6655.17. Recommendations on methods for dosage formstesting............................................................................................... 665

5.1.7. Viral safety.............................................................................. 5185.1.8. Microbiological quality of herbal medicinal products fororal use ............................................................................................ 519

5.1.9. Guidelines for using the test for sterility ........................ 5195.1. General texts on microbiology .............................................. 5035.2.1. Terminology used in monographs on biologicalproducts ........................................................................................... 527

5.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines ............................. 527

5.2.3. Cell substrates for the production of vaccines for humanuse..................................................................................................... 530

5.2.4. Cell cultures for the production of veterinaryvaccines............................................................................................ 533

5.2.5. Substances of animal origin for the production ofimmunological veterinary medicinal products........................ 535

5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ................................................................................... 536

5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera .................................................................................... 538

5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ........................................................................................... 539

5.2.9. Evaluation of safety of each batch of veterinary vaccinesand immunosera ............................................................................ 547

5.2. General texts on biological products................................... 5275.3. Statistical analysis of results of biological assays andtests................................................................................................... 551

5.4. Residual solvents ..................................................................... 5835.5. Alcoholimetric tables .............................................................. 5935.6. Assay of interferons................................................................. 6075.7. Table of physical characteristics of radionuclides mentionedin the European Pharmacopoeia ............................................... 611

5.8. Pharmacopoeial harmonisation ........................................... 6215.9. Polymorphism........................................................................... 627

AAbbreviations and symbols (1.) ..........................................................3Abnormal toxicity (2.6.9.)............................................................... 162Absorption spectrophotometry, infrared (2.2.24.) ...................... 38Absorption spectrophotometry, ultraviolet and visible(2.2.25.) .............................................................................................. 40

Acacia................................................................................................1043Acacia, spray-dried ......................................................................... 1301Acamprosate calcium .................................................................... 1301Acarbose...........................................................................................1302Acebutolol hydrochloride.............................................................1304Aceclofenac......................................................................................1306Acemetacin ......................................................................................1307Acesulfame potassium ..................................................................1309Acetate trihydrate, sodium...........................................................2908Acetazolamide................................................................................. 1310Acetic acid, glacial ......................................................................... 1311Acetic acid in synthetic peptides (2.5.34.) .................................. 150



Acetone............................................................................................. 1312Acetylcholine chloride .................................................................. 1313Acetylcysteine ................................................................................. 1313β-Acetyldigoxin ............................................................................... 1315Acetylsalicylic acid ......................................................................... 1317Acetyltryptophan, N- ..................................................................... 1319Acetyltyrosine, N- ...........................................................................1320Aciclovir ........................................................................................... 1321Acid value (2.5.1.)............................................................................. 137Acitretin............................................................................................1323Actinobacillosis vaccine (inactivated), porcine .......................... 926Activated charcoal..........................................................................1649Activated coagulation factors (2.6.22.)........................................ 185Adapalene ........................................................................................1324Additives, plastic (3.1.13.)............................................................... 352Adenine ............................................................................................1326Adeno-associated-virus vectors for human use ......................... 656Adenosine ........................................................................................1327Adipic acid .......................................................................................1328Adrenaline .......................................................................................1329Adrenaline tartrate ........................................................................1330Adsorption, gas, specific surface area by (2.9.26.).................... 291Adsorption, gas, specific surface area by (2.9.26.) (5.8.)......... 622Aerodynamic assessment of fine particles in preparations forinhalation (2.9.18.) ........................................................................ 274

Aflatoxin B1 in herbal drugs, determination of (2.8.18.)......... 244Agar...................................................................................................1044Agnus castus fruit..........................................................................1044Agrimony .........................................................................................1046Air, medicinal .................................................................................. 1331Air, synthetic medicinal ................................................................1333Alanine .............................................................................................1334Albendazole.....................................................................................1335Albumin solution, human............................................................. 2165Alchemilla ........................................................................................1047Alcoholimetric tables (2.9.10.) ...................................................... 268Alcoholimetric tables (5.5.) ............................................................ 593Alcuronium chloride......................................................................1336Alendronate, sodium .....................................................................2908Alexandrian senna pods ...............................................................1238Alfacalcidol ......................................................................................1337Alfadex..............................................................................................1338Alfentanil hydrochloride...............................................................1339Alfuzosin hydrochloride ............................................................... 1341Alginate, sodium.............................................................................2909Alginic acid ......................................................................................1342Alkaline-earth metals and magnesium (2.4.7.) ...........................114Alkaline impurities in fatty oils (2.4.19.)..................................... 119Allantoin...........................................................................................1342Allergen products............................................................................. 671Allopurinol.......................................................................................1343all-rac-α-Tocopherol....................................................................... 3104all-rac-α-Tocopheryl acetate ........................................................ 3106Almagate ..........................................................................................1345Almond oil, refined ........................................................................1346Almond oil, virgin ..........................................................................1347Aloes, Barbados..............................................................................1047Aloes, Cape ......................................................................................1048Aloes dry extract, standardised...................................................1049Alphacyclodextrin ..........................................................................1338Alprazolam ......................................................................................1347Alprenolol hydrochloride .............................................................1349Alprostadil .......................................................................................1350Alteplase for injection ...................................................................1352Alternative methods for control of microbiological quality(5.1.6.)............................................................................................... 508

Altizide .............................................................................................1356Alum..................................................................................................1357Aluminium (2.4.17.) ......................................................................... 118Aluminium chloride hexahydrate ...............................................1357Aluminium hydroxide, hydrated, for adsorption.....................1357Aluminium in adsorbed vaccines (2.5.13.)...................................141Aluminium magnesium silicate...................................................1358

Aluminium oxide, hydrated..........................................................1359Aluminium phosphate gel ............................................................1360Aluminium phosphate, hydrated ................................................ 1361Aluminium sodium silicate .......................................................... 1361Aluminium sulfate..........................................................................1362Alverine citrate ...............................................................................1363Amantadine hydrochloride ..........................................................1364Ambroxol hydrochloride...............................................................1365Amfetamine sulfate........................................................................1366Amidotrizoate, sodium.................................................................. 2910Amidotrizoic acid dihydrate.........................................................1366Amikacin ..........................................................................................1367Amikacin sulfate.............................................................................1369Amiloride hydrochloride...............................................................1370Amino acid analysis (2.2.56.) ........................................................... 88Amino acid analysis (2.2.56.) (5.8.) .............................................. 621Aminobenzoic acid, 4- ...................................................................1371Aminocaproic acid .........................................................................1373Aminoglutethimide........................................................................1373Aminophylline, anhydrous ...........................................................3068Aminophylline hydrate..................................................................3069Aminosalicylate dihydrate, sodium ............................................ 2911Amiodarone hydrochloride ..........................................................1375Amisulpride .....................................................................................1376Amitriptyline hydrochloride ........................................................1377Amlodipine besilate .......................................................................1379Ammonia (13N) injection ................................................................. 965Ammonia solution, concentrated ...............................................1380Ammonio methacrylate copolymer (type A) ............................ 1381Ammonio methacrylate copolymer (type B) ............................1382Ammonium (2.4.1.) .......................................................................... 113Ammonium bromide......................................................................1382Ammonium chloride......................................................................1383Ammonium glycyrrhizate.............................................................1384Ammonium hydrogen carbonate ................................................1385Amobarbital.....................................................................................1385Amobarbital sodium ......................................................................1386Amoxicillin sodium ........................................................................1386Amoxicillin trihydrate ...................................................................1389Amperometric titration (2.2.19.) ..................................................... 34Amphotericin B .............................................................................. 1391Ampicillin, anhydrous ..................................................................1393Ampicillin sodium ..........................................................................1395Ampicillin trihydrate .....................................................................1397Amylmetacresol ..............................................................................1399Anaemia vaccine (live), chicken, infectious ................................ 910Anaesthetic ether ...........................................................................1968Analysis, thermal (2.2.34.)................................................................ 54Analytical sieving, particle-size distribution estimation by(2.9.38.) ............................................................................................ 313

Analytical sieving, particle-size distribution estimation by(2.9.38.) (5.8.) ................................................................................. 623

Angelica root ...................................................................................1049Animal anti-T lymphocyte immunoglobulin for human use ..1404Animal immunosera for human use............................................. 678Animal spongiform encephalopathies, products with risk oftransmitting agents of................................................................... 686

Animal spongiform encephalopathy agents, minimising the riskof transmitting via human and veterinary medicinal products(5.2.8.) .............................................................................................. 539

Aniseed .............................................................................................1052Anise oil............................................................................................1050Anisidine value (2.5.36.) ................................................................. 150Antazoline hydrochloride............................................................. 1401Anthrax spore vaccine (live) for veterinary use......................... 847Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates) ............................................................................. 745

Anti-A and anti-B haemagglutinins (indirect method)(2.6.20.) ............................................................................................ 180

Antibiotics, microbiological assay of (2.7.2.) .............................. 202Antibodies (anti-D) in human immunoglobulin for intravenousadministration, test for (2.6.26.) ................................................. 191

Antibodies for human use, monoclonal ...................................... 682



Anticoagulant and preservative solutions for human blood......................................................................................................... 1401

Anticomplementary activity of immunoglobulin (2.6.17.)....... 177Anti-D antibodies in human immunoglobulin for intravenousadministration, test for (2.6.26.) ................................................. 191

Anti-D immunoglobulin for intravenous administration,human ............................................................................................ 2167

Anti-D immunoglobulin, human ................................................. 2166Anti-D immunoglobulin, human, assay of (2.7.13.)................... 220Antimicrobial preservation, efficacy of (5.1.3.) .......................... 505Antiserum, European viper venom .............................................. 953Antithrombin III concentrate, human ....................................... 2168Antithrombin III, human, assay of (2.7.17.) ................................ 224Anti-T lymphocyte immunoglobulin for human use, animal ..1404Apomorphine hydrochloride .......................................................1407Apparatus (2.1.) .................................................................................. 15Apparent dissolution (2.9.43.) ....................................................... 320Application of the F0 concept to steam sterilisation of aqueouspreparations (5.1.5.) ...................................................................... 508

Aprotinin ..........................................................................................1408Aprotinin concentrated solution................................................. 1411Arachis oil, hydrogenated ............................................................ 1413Arachis oil, refined......................................................................... 1413Arginine............................................................................................ 1414Arginine aspartate ......................................................................... 1415Arginine hydrochloride................................................................. 1415Argon ................................................................................................ 1416Aristolochic acids in herbal drugs, test for (2.8.21) ................. 247Arnica flower...................................................................................1053Arnica tincture................................................................................1055Arsenic (2.4.2.) .................................................................................. 113Arsenious trioxide for homoeopathic preparations................1286Articaine hydrochloride................................................................ 1417Artichoke leaf..................................................................................1056Artichoke leaf dry extract ............................................................1058Ascorbate, calcium.........................................................................1548Ascorbate, sodium ......................................................................... 2912Ascorbic acid ................................................................................... 1418Ascorbyl palmitate .........................................................................1420Ash insoluble in hydrochloric acid (2.8.1.)................................. 239Ash leaf.............................................................................................1059Ash, sulfated (2.4.14.)...................................................................... 118Ash, sulfated (2.4.14.) (5.8.) ........................................................... 622Asparagine monohydrate ............................................................. 1421Aspartame........................................................................................ 1421Aspartic acid....................................................................................1423Assay of 1,8-cineole in essential oils (2.8.11.) ............................ 240Assay of diphtheria vaccine (adsorbed) (2.7.6.) ......................... 209Assay of heparin (2.7.5.) ................................................................. 208Assay of heparin in coagulation factors (2.7.12.) ...................... 220Assay of hepatitis A vaccine (2.7.14.) ........................................... 222Assay of hepatitis B vaccine (rDNA) (2.7.15.) ............................ 223Assay of human anti-D immunoglobulin (2.7.13.)..................... 220Assay of human antithrombin III (2.7.17.) .................................. 224Assay of human coagulation factor II (2.7.18.).......................... 224Assay of human coagulation factor IX (2.7.11.)......................... 219Assay of human coagulation factor VII (2.7.10.) ....................... 219Assay of human coagulation factor VIII (2.7.4.)........................ 207Assay of human coagulation factor X (2.7.19.) .......................... 225Assay of human coagulation factor XI (2.7.22.) ........................ 227Assay of human plasmin inhibitor (2.7.25.)................................ 230Assay of human protein C (2.7.30.) .............................................. 234Assay of human protein S (2.7.31.)............................................... 235Assay of human von Willebrand factor (2.7.21.) ....................... 226Assay of interferons (5.6.) .............................................................. 607Assay of pertussis vaccine (2.7.7.)................................................. 213Assay of pertussis vaccine (acellular) (2.7.16.) .......................... 223Assay of poliomyelitis vaccine (inactivated), in vivo (2.7.20.) .. 225Assay of tetanus vaccine (adsorbed) (2.7.8.) .............................. 214Assays (2.5.) ....................................................................................... 137Astragalus mongholicus root ......................................................1060Atenolol ............................................................................................1424Atomic absorption spectrometry (2.2.23.) .................................... 36

Atomic emission spectrometry (2.2.22.)........................................ 35Atomic emission spectrometry, inductively coupled plasma-(2.2.57.) .............................................................................................. 94

Atracurium besilate .......................................................................1425Atropine ...........................................................................................1427Atropine sulfate ..............................................................................1429Aujeszky’s disease vaccine (inactivated) for pigs...................... 847Aujeszky’s disease vaccine (live) for pigs for parenteraladministration ................................................................................ 849

Avian infectious bronchitis vaccine (inactivated)...................... 851Avian infectious bronchitis vaccine (live) ................................... 852Avian infectious bursal disease vaccine (inactivated) .............. 854Avian infectious bursal disease vaccine (live) ............................ 856Avian infectious encephalomyelitis vaccine (live) ..................... 857Avian infectious laryngotracheitis vaccine (live)....................... 859Avian live virus vaccines : tests for extraneous agents in batchesof finished product (2.6.25.) ........................................................ 188

Avian paramyxovirus 1 (Newcastle disease) vaccine(inactivated) .................................................................................... 921

Avian paramyxovirus 3 vaccine (inactivated)............................. 860Avian tuberculin purified protein derivative............................ 3161Avian viral tenosynovitis vaccine (live)........................................ 861Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) ............................................................................................ 185

Azaperone for veterinary use ......................................................1430Azathioprine.................................................................................... 1431Azelastine hydrochloride..............................................................1433Azithromycin...................................................................................1434

BB19 virus (B19V), validation of nucleic acid amplificationtechniques for the quantification of B19V DNA in plasmapools : guidelines............................................................................ 181

Bacampicillin hydrochloride........................................................1439Bacitracin.........................................................................................1440Bacitracin zinc ................................................................................1443Baclofen ...........................................................................................1445Bacterial endotoxins (2.6.14.)........................................................ 171Bacterial endotoxins, guidelines for using the test for(5.1.10.) ............................................................................................ 520

Bambuterol hydrochloride...........................................................1446Barbados aloes ...............................................................................1047Barbital.............................................................................................1447Barium chloride dihydrate for homoeopathic preparations ..1287Barium sulfate ................................................................................1448Basic butylated methacrylate copolymer..................................1448BCG for immunotherapy ................................................................ 746BCG vaccine, freeze-dried .............................................................. 747Bearberry leaf ................................................................................. 1061Beclometasone dipropionate, anhydrous .................................1449Beclometasone dipropionate monohydrate ............................. 1451Bee for homoeopathic preparations, honey.............................1292Beeswax, white ...............................................................................1453Beeswax, yellow..............................................................................1454Belladonna leaf...............................................................................1062Belladonna leaf dry extract, standardised ................................1064Belladonna leaf tincture, standardised .....................................1065Belladonna, prepared ....................................................................1066Benazepril hydrochloride.............................................................1454Bendroflumethiazide ....................................................................1456Benfluorex hydrochloride ............................................................1457Benperidol .......................................................................................1458Benserazide hydrochloride ..........................................................1459Bentonite .........................................................................................1460Benzalkonium chloride................................................................. 1461Benzalkonium chloride solution ................................................1463Benzathine benzylpenicillin ........................................................ 1471Benzbromarone..............................................................................1465Benzethonium chloride ................................................................1466Benzocaine ......................................................................................1466Benzoic acid ....................................................................................1467Benzoin, Siam.................................................................................1067



Benzoin, Sumatra ..........................................................................1068Benzoin tincture, Siam .................................................................1069Benzoin tincture, Sumatra...........................................................1069Benzoyl peroxide, hydrous ..........................................................1468Benzyl alcohol ................................................................................1469Benzyl benzoate .............................................................................1470Benzylpenicillin, benzathine ....................................................... 1471Benzylpenicillin potassium..........................................................1473Benzylpenicillin, procaine............................................................ 1474Benzylpenicillin sodium ............................................................... 1476Betacarotene ...................................................................................1477Betacyclodextrin ............................................................................1478Betacyclodextrin, poly(hydroxypropyl) ether .......................... 2210Betadex ............................................................................................1478Betahistine dihydrochloride ........................................................1479Betahistine mesilate ......................................................................1480Betamethasone............................................................................... 1481Betamethasone acetate ................................................................1483Betamethasone dipropionate ......................................................1485Betamethasone sodium phosphate............................................1486Betamethasone valerate ...............................................................1488Betaxolol hydrochloride ...............................................................1489Bezafibrate ......................................................................................1490Bifonazole........................................................................................ 1491Bilberry fruit, dried .......................................................................1070Bilberry fruit dry extract, fresh, refined and standardised...1130Bilberry fruit, fresh........................................................................1070Biological assays (2.7.) .................................................................... 201Biological assays and tests, statistical analysis of results of(5.3.).................................................................................................. 551

Biological indicators of sterilisation (5.1.2.) .............................. 504Biological products, general texts on (5.2.)................................ 527Biological products, terminology used in monographs on(5.2.1.)............................................................................................... 527

Biological tests (2.6.) ....................................................................... 153Biotin ................................................................................................1492Biperiden hydrochloride...............................................................1493Biphasic insulin injection.............................................................2243Biphasic isophane insulin injection ...........................................2244Birch leaf..........................................................................................1071Bisacodyl..........................................................................................1495Bismuth subcarbonate..................................................................1496Bismuth subgallate........................................................................1497Bismuth subnitrate, heavy ...........................................................1498Bismuth subsalicylate ...................................................................1498Bisoprolol fumarate.......................................................................1499Bistort rhizome ..............................................................................1072Bitter fennel ....................................................................................1124Bitter-fennel fruit oil......................................................................1073Bitter-fennel herb oil .....................................................................1075Bitterness value (2.8.15.)................................................................ 244Bitter-orange epicarp and mesocarp..........................................1077Bitter-orange-epicarp and mesocarp tincture ..........................1078Bitter-orange flower ......................................................................1078Bitter-orange-flower oil ................................................................. 1194Black horehound ...........................................................................1079Bleomycin sulfate...........................................................................1502Blood and blood components, empty sterile containers ofplasticised poly(vinyl chloride) for (3.2.4.) ............................... 370

Blood and blood components, materials for containers for(3.1.1.)............................................................................................... 329

Blood and blood components, sets for the transfusion of(3.2.6.) .............................................................................................. 371

Blood and blood components, sterile plastic containers for(3.2.3.) .............................................................................................. 369

Blood, anticoagulant and preservative solutions for ............. 1401Blood, sterile containers of plasticised poly(vinyl chloride)containing anticoagulant solution (3.2.5.) ............................... 371

Bogbean leaf ...................................................................................1080Boiling point (2.2.12.) ........................................................................31Boldo leaf......................................................................................... 1081Boldo leaf dry extract....................................................................1083Borage (starflower) oil, refined...................................................1503

Borax ................................................................................................1503Boric acid.........................................................................................1504Botulinum antitoxin ........................................................................ 949Botulinum toxin type A for injection.........................................1504Bovine infectious rhinotracheitis vaccine (live) ........................ 908Bovine insulin.................................................................................2239Bovine leptospirosis vaccine (inactivated).................................. 862Bovine parainfluenza virus vaccine (live)................................... 864Bovine respiratory syncytial virus vaccine (live)....................... 865Bovine serum..................................................................................1506Bovine tuberculin purified protein derivative ......................... 3161Bovine viral diarrhoea vaccine (inactivated).............................. 866Bromazepam ...................................................................................1507Bromhexine hydrochloride ..........................................................1508Bromocriptine mesilate ................................................................1509Bromperidol .................................................................................... 1511Bromperidol decanoate ................................................................ 1512Brompheniramine maleate........................................................... 1514Brotizolam ....................................................................................... 1515Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) forveterinary use ................................................................................. 867

Buccal tablets and sublingual tablets.......................................... 723Buckwheat herb .............................................................................1084Budesonide...................................................................................... 1516Bufexamac ....................................................................................... 1518Buffer solutions (4.1.3.) .................................................................. 489Buflomedil hydrochloride ............................................................ 1519Bulk density and tapped density of powders (2.9.34.)............. 305Bumetanide .....................................................................................1520Bupivacaine hydrochloride .......................................................... 1521Buprenorphine ...............................................................................1523Buprenorphine hydrochloride ....................................................1524Buserelin..........................................................................................1526Buspirone hydrochloride..............................................................1527Busulfan...........................................................................................1529Butcher’s broom.............................................................................1085Butylated methacrylate copolymer, basic.................................1448Butylhydroxyanisole...................................................................... 1531Butylhydroxytoluene..................................................................... 1531Butyl parahydroxybenzoate.........................................................1530

CCabergoline .....................................................................................1535Cachets ............................................................................................... 709Cadmium sulfate hydrate for homoeopathic preparations...1287Caffeine ............................................................................................1536Caffeine monohydrate...................................................................1537Calcifediol ........................................................................................1538Calcipotriol, anhydrous ................................................................1539Calcipotriol monohydrate ............................................................1542Calcitonin (salmon)........................................................................1544Calcitriol...........................................................................................1546Calcium (2.4.3.)................................................................................. 113Calcium acetate, anhydrous.........................................................1547Calcium ascorbate..........................................................................1548Calcium carbonate .........................................................................1549Calcium carboxymethylcellulose ................................................1589Calcium chloride dihydrate..........................................................1550Calcium chloride hexahydrate ....................................................1550Calcium dobesilate monohydrate ............................................... 1551Calcium edetate, sodium .............................................................. 2916Calcium folinate .............................................................................1552Calcium glucoheptonate...............................................................1554Calcium gluconate .........................................................................1555Calcium gluconate, anhydrous ...................................................1555Calcium gluconate for injection..................................................1556Calcium glycerophosphate...........................................................1557Calcium hydrogen phosphate, anhydrous ................................1558Calcium hydrogen phosphate dihydrate ...................................1559Calcium hydroxide .........................................................................1560Calcium in adsorbed vaccines (2.5.14.) ........................................141



Calcium iodide tetrahydrate for homoeopathic prepara-tions ................................................................................................1288

Calcium lactate, anhydrous ......................................................... 1561Calcium lactate monohydrate ..................................................... 1561Calcium lactate pentahydrate .....................................................1562Calcium lactate trihydrate............................................................1562Calcium levofolinate pentahydrate ............................................1563Calcium levulinate dihydrate.......................................................1565Calcium pantothenate...................................................................1566Calcium pentetate (sodium) for radiopharmaceuticalpreparations.................................................................................... 987

Calcium phosphate ........................................................................1567Calcium stearate.............................................................................1567Calcium sulfate dihydrate ............................................................1569Calendula flower ............................................................................1086Calf coronavirus diarrhoea vaccine (inactivated)...................... 868Calf rotavirus diarrhoea vaccine (inactivated)........................... 869Calicivirosis vaccine (inactivated), feline..................................... 895Calicivirosis vaccine (live), feline .................................................. 896Camphor, D- .....................................................................................1569Camphor, racemic ..........................................................................1571Canine adenovirus vaccine (inactivated) .................................... 870Canine adenovirus vaccine (live) .................................................. 871Canine distemper vaccine (live) .................................................... 872Canine leptospirosis vaccine (inactivated).................................. 874Canine parainfluenza virus vaccine (live)................................... 875Canine parvovirosis vaccine (inactivated)................................... 876Canine parvovirosis vaccine (live) ................................................ 877Cape aloes........................................................................................1048Capillary electrophoresis (2.2.47.).................................................. 77Capillary electrophoresis (2.2.47.) (5.8.) ..................................... 621Capillary viscometer method (2.2.9.)............................................. 27Caprylate, sodium .......................................................................... 2917Caprylic acid....................................................................................1571Caprylocaproyl macrogolglycerides...........................................1572Capsicum..........................................................................................1087Capsicum oleoresin, refined and quantified ............................1089Capsicum tincture, standardised ................................................1090Capsules ............................................................................................. 707Capsules and tablets, disintegration of (2.9.1.) ......................... 253Capsules, gastro-resistant............................................................... 708Capsules, hard .................................................................................. 708Capsules, intrauterine..................................................................... 715Capsules, modified-release ............................................................. 708Capsules, oromucosal ..................................................................... 723Capsules, rectal................................................................................. 733Capsules, soft .................................................................................... 708Capsules, vaginal.............................................................................. 739Captopril ..........................................................................................1573Caraway fruit...................................................................................1090Caraway oil ...................................................................................... 1091Carbachol.........................................................................................1575Carbamazepine ...............................................................................1576Carbasalate calcium.......................................................................1577Carbidopa ........................................................................................1579Carbimazole ....................................................................................1580Carbocisteine .................................................................................. 1581Carbomers ....................................................................................... 1581Carbon dioxide ...............................................................................1583Carbon dioxide in gases (2.5.24.) ................................................. 143Carbon monoxide...........................................................................1584Carbon monoxide (15O) ................................................................... 965Carbon monoxide in gases (2.5.25.)............................................. 144Carboplatin......................................................................................1585Carboprost trometamol ................................................................1586Carboxymethylcellulose................................................................1588Carboxymethylcellulose calcium ................................................1589Carboxymethylcellulose sodium.................................................1589Carboxymethylcellulose sodium, cross-linked .........................1770Carboxymethylcellulose sodium, low-substituted...................1590Carisoprodol....................................................................................1587Carmellose.......................................................................................1588Carmellose calcium........................................................................1589

Carmellose sodium ........................................................................1589Carmellose sodium and microcrystalline cellulose ................2507Carmellose sodium, low-substituted ..........................................1590Carmustine ...................................................................................... 1591Carnauba wax .................................................................................1592Carprofen for veterinary use .......................................................1592Carrageenan....................................................................................1593Carteolol hydrochloride................................................................1594Carvedilol.........................................................................................1595Cascara .............................................................................................1092Cascara dry extract, standardised ..............................................1094Cassia oil ..........................................................................................1095Castor oil, hydrogenated ..............................................................1596Castor oil, polyoxyl ........................................................................2398Castor oil, polyoxyl hydrogenated..............................................2397Castor oil, refined ..........................................................................1597Castor oil, virgin.............................................................................1598Catgut, sterile..................................................................................1027Catgut, sterile, in distributor for veterinary use .....................1037CD34/CD45+ cells in haematopoietic products, numeration of(2.7.23.) ............................................................................................ 228

Cefaclor ............................................................................................1599Cefadroxil monohydrate ...............................................................1600Cefalexin monohydrate.................................................................1602Cefalotin sodium ............................................................................1603Cefamandole nafate .......................................................................1605Cefapirin sodium............................................................................1606Cefatrizine propylene glycol........................................................1607Cefazolin sodium............................................................................1608Cefepime dihydrochloride monohydrate .................................. 1610Cefixime ........................................................................................... 1612Cefoperazone sodium ................................................................... 1613Cefotaxime sodium ........................................................................ 1615Cefoxitin sodium ............................................................................ 1617Cefpodoxime proxetil .................................................................... 1618Cefradine..........................................................................................1620Ceftazidime pentahydrate ............................................................1622Ceftazidime pentahydrate with sodium carbonate forinjection .........................................................................................1624

Ceftriaxone sodium........................................................................1626Cefuroxime axetil ...........................................................................1627Cefuroxime sodium........................................................................1629Celiprolol hydrochloride...............................................................1630Cell count and viability, nucleated (2.7.29.) ............................... 233Cell cultures for the production of veterinary vaccines(5.2.4.) .............................................................................................. 533

Cell substrates for the production of vaccines for human use(5.2.3.) .............................................................................................. 530

Cellular products, microbiological control of (2.6.27.) ............ 191Cellulose acetate ............................................................................ 1631Cellulose acetate butyrate............................................................1632Cellulose acetate phthalate..........................................................1633Cellulose, microcrystalline...........................................................1634Cellulose (microcrystalline) and carmellose sodium..............2507Cellulose, powdered ......................................................................1638Centaury ..........................................................................................1095Centella ............................................................................................1096Cetirizine dihydrochloride ........................................................... 1641Cetostearyl alcohol ........................................................................1643Cetostearyl alcohol (type A), emulsifying .................................1643Cetostearyl alcohol (type B), emulsifying.................................1645Cetostearyl isononanoate.............................................................1646Cetostearyl sulfate, sodium .........................................................2920Cetrimide .........................................................................................1646Cetyl alcohol ...................................................................................1647Cetyl palmitate................................................................................1648Cetylpyridinium chloride..............................................................1648Ceylon cinnamon bark oil ............................................................ 1101Ceylon cinnamon leaf oil.............................................................. 1102CFC assay for human haematopoietic progenitor cells(2.7.28.) ............................................................................................ 232

Chamomile flower, Roman...........................................................1098



Characterisation of crystalline and partially crystalline solidsby X-ray powder diffraction (XRPD) (2.9.33.) .......................... 301

Characters section in monographs (5.11.).................................. 637Charcoal, activated ........................................................................1649Chenodeoxycholic acid ................................................................1650Chewing gums, medicated ............................................................. 709Chewing gums, medicated, dissolution test for (2.9.25.) ........ 289Chicken anaemia vaccine (live), infectious................................. 910Chicken flocks free from specified pathogens for the productionand quality control of vaccines (5.2.2.) ..................................... 527

Chitosan hydrochloride ................................................................ 1651Chlamydiosis vaccine (inactivated), feline ................................. 897Chloral hydrate...............................................................................1652Chlorambucil...................................................................................1653Chloramine ...................................................................................... 3118Chloramphenicol............................................................................1653Chloramphenicol palmitate .........................................................1654Chloramphenicol sodium succinate...........................................1655Chlorcyclizine hydrochloride ......................................................1656Chlordiazepoxide ...........................................................................1657Chlordiazepoxide hydrochloride ................................................1658Chlorhexidine diacetate................................................................1659Chlorhexidine digluconate solution ..........................................1660Chlorhexidine dihydrochloride ...................................................1662Chlorides (2.4.4.) .............................................................................. 113Chlorobutanol, anhydrous ...........................................................1663Chlorobutanol hemihydrate ........................................................1663Chlorocresol ....................................................................................1664Chloroquine phosphate ................................................................1665Chloroquine sulfate .......................................................................1665Chlorothiazide ................................................................................1666Chlorphenamine maleate .............................................................1667Chlorpromazine hydrochloride...................................................1668Chlorpropamide..............................................................................1669Chlorprothixene hydrochloride ..................................................1670Chlortalidone ..................................................................................1671Chlortetracycline hydrochloride.................................................1673Cholecalciferol ................................................................................ 1674Cholecalciferol concentrate (oily form).....................................1675Cholecalciferol concentrate (powder form)..............................1677Cholecalciferol concentrate (water-dispersible form).............1678Cholera vaccine ................................................................................ 748Cholera vaccine, freeze-dried ........................................................ 749Cholera vaccine (inactivated, oral) ............................................... 749Cholesterol ......................................................................................1680Cholesterol in oils rich in omega-3 acids, total (2.4.32.) ......... 133Chondroitin sulfate sodium ......................................................... 1681Chromatographic separation techniques (2.2.46.) ..................... 70Chromatography, gas (2.2.28.)........................................................ 43Chromatography, liquid (2.2.29.) ................................................... 45Chromatography, paper (2.2.26.).....................................................41Chromatography, size-exclusion (2.2.30.)..................................... 46Chromatography, supercritical fluid (2.2.45.) ............................. 70Chromatography, thin-layer (2.2.27.) ............................................. 42Chromium (51Cr) edetate injection ............................................... 966Chymotrypsin..................................................................................1683Ciclopirox.........................................................................................1684Ciclopirox olamine .........................................................................1686Ciclosporin ......................................................................................1687Cilastatin sodium ...........................................................................1688Cilazapril ..........................................................................................1690Cimetidine........................................................................................ 1691Cimetidine hydrochloride.............................................................1693Cinchocaine hydrochloride..........................................................1694Cinchona bark ................................................................................1098Cinchona liquid extract, standardised....................................... 1100Cineole..............................................................................................1695Cineole in essential oils, 1,8-, assay of (2.8.11.) ......................... 240Cinnamon ........................................................................................ 1101Cinnamon bark oil, Ceylon .......................................................... 1101Cinnamon leaf oil, Ceylon ............................................................ 1102Cinnamon tincture......................................................................... 1103Cinnarizine ......................................................................................1696

Ciprofibrate .....................................................................................1697Ciprofloxacin...................................................................................1698Ciprofloxacin hydrochloride........................................................1700Circular dichroism (2.2.41.) ............................................................. 65Cisplatin ........................................................................................... 1701Citalopram hydrobromide ............................................................1703Citalopram hydrochloride ............................................................1704Citric acid, anhydrous ...................................................................1705Citric acid monohydrate ...............................................................1706Citronella oil.................................................................................... 1103Cladribine ........................................................................................1707Clarithromycin................................................................................1708Clarity and degree of opalescence of liquids (2.2.1.)...................21Clary sage oil................................................................................... 1104Classical swine-fever vaccine (live, prepared in cell cultures) .. 940Clazuril for veterinary use ........................................................... 1710Clebopride malate .......................................................................... 1712Clemastine fumarate ..................................................................... 1713Clenbuterol hydrochloride........................................................... 1715Clindamycin hydrochloride.......................................................... 1716Clindamycin phosphate ................................................................ 1717Clioquinol ........................................................................................ 1718Clobazam ......................................................................................... 1719Clobetasol propionate...................................................................1720Clobetasone butyrate ....................................................................1722Clodronate disodium tetrahydrate .............................................1723Clofazimine......................................................................................1724Clofibrate .........................................................................................1725Clomifene citrate ............................................................................1726Clomipramine hydrochloride.......................................................1727Clonazepam.....................................................................................1729Clonidine hydrochloride...............................................................1730Clopamide........................................................................................ 1731Clorazepate, dipotassium.............................................................1869Closantel sodium dihydrate for veterinary use .......................1732Clostridium botulinum vaccine for veterinary use ................... 878Clostridium chauvoei vaccine for veterinary use...................... 879Clostridium novyi alpha antitoxin for veterinary use .............. 957Clostridium novyi (type B) vaccine for veterinary use............. 879Clostridium perfringens beta antitoxin for veterinary use .... 958Clostridium perfringens epsilon antitoxin for veterinary use........................................................................................................... 959

Clostridium perfringens vaccine for veterinary use ................. 881Clostridium septicum vaccine for veterinary use...................... 883Closures and containers for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.).............. 342

Closures and containers for pharmaceutical use, plastic(3.2.2.) .............................................................................................. 368

Closures and tubing, silicone elastomer for (3.1.9.) ................. 347Closures for containers for aqueous parenteral preparations, forpowders and for freeze-dried powders, rubber (3.2.9.) ......... 374

Clotrimazole....................................................................................1734Clove ................................................................................................. 1105Clove oil ........................................................................................... 1106Cloxacillin sodium..........................................................................1735Clozapine .........................................................................................1737Coagulation factor II, assay of (2.7.18.)....................................... 224Coagulation factor IX, human..................................................... 2172Coagulation factor IX, human, assay of (2.7.11.)....................... 219Coagulation factors, activated (2.6.22.)....................................... 185Coagulation factors, assay of heparin (2.7.12.) ......................... 220Coagulation factor VII, human ................................................... 2169Coagulation factor VII, human, assay of (2.7.10.)..................... 219Coagulation factor VIII, human.................................................. 2170Coagulation factor VIII, human, assay of (2.7.4.)...................... 207Coagulation factor VIII (rDNA), human ................................... 2171Coagulation factor X, assay of (2.7.19.) ....................................... 225Coagulation factor XI, human..................................................... 2173Coagulation factor XI, human, assay of (2.7.22.) ...................... 227Coated granules ............................................................................... 714Coated tablets ................................................................................... 737Cocaine hydrochloride..................................................................1738Coccidiosis vaccine (live) for chickens ........................................ 884



Coconut oil, refined.......................................................................1739Cocoyl caprylocaprate................................................................... 1740Codeine ............................................................................................ 1740Codeine hydrochloride dihydrate............................................... 1742Codeine phosphate hemihydrate................................................ 1743Codeine phosphate sesquihydrate ............................................. 1745Codergocrine mesilate .................................................................. 1747Cod-liver oil, farmed ...................................................................... 1748Cod-liver oil (type A)......................................................................1752Cod-liver oil (type B)......................................................................1756Cola ................................................................................................... 1107Colchicine ........................................................................................1759Cold-water vibriosis vaccine (inactivated) for salmonids......... 943Colestyramine ................................................................................. 1761Colibacillosis vaccine (inactivated), neonatal piglet................. 918Colibacillosis vaccine (inactivated), neonatal ruminant .......... 920Colistimethate sodium .................................................................. 1762Colistin sulfate................................................................................ 1763Colloidal anhydrous silica ............................................................2901Colloidal hydrated silica ...............................................................2902Colloidal silica, hydrophobic .......................................................2903Colloidal silver, for external use .................................................2904Colony-forming cell assay for human haematopoietic progenitorcells (2.7.28.) ................................................................................... 232

Colophony ....................................................................................... 1107Coloration of liquids (2.2.2.)............................................................ 22Common stinging nettle for homoeopathic preparations.....1288Comparative table of porosity of sintered-glass filters (2.1.2.).. 15Complexometric titrations (2.5.11.).............................................. 140Composition of fatty acids by gas chromatography (2.4.22.).. 119Composition of fatty acids in oils rich in omega-3 acids(2.4.29.) ............................................................................................ 130

Compressed lozenges...................................................................... 723Concentrated solutions for haemodialysis ............................... 2136Concentrates for injections or infusions..................................... 725Concentrates for intrauterine solutions...................................... 715Conductivity (2.2.38.) ........................................................................ 59Coneflower herb, purple .............................................................. 1218Coneflower root, narrow-leaved.................................................. 1193Coneflower root, pale....................................................................1208Coneflower root, purple ............................................................... 1219Conjugated estrogens ...................................................................1958Consistency by penetrometry, measurement of (2.9.9.) .......... 267Containers (3.2.)............................................................................... 363Containers and closures for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.).............. 342

Containers and closures for pharmaceutical use, plastic(3.2.2.) .............................................................................................. 368

Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ......... 345

Containers for aqueous solutions for infusion, plastic(3.2.2.1.) ........................................................................................... 368

Containers for aqueous solutions for intravenous infusion,materials based on plasticised poly(vinyl chloride) for(3.1.14.) ............................................................................................ 355

Containers for dry dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.)............................................................................................. 350

Containers for human blood and blood components, materialsbased on plasticised poly(vinyl chloride) for (3.1.1.1.) .......... 329

Containers for human blood and blood components, materialsfor (3.1.1.) ........................................................................................ 329

Containers for human blood and blood components, plastic,sterile (3.2.3.) .................................................................................. 369

Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for (3.1.10.) ... 349

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene with additives for (3.1.5.) ........... 338

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for (3.1.4.) ..... 337

Containers for pharmaceutical use, glass (3.2.1.)..................... 363Containers for preparations not for parenteral use, polyethyleneterephthalate for (3.1.15) ............................................................. 357

Containers of plasticised poly(vinyl chloride) for human bloodand blood components, empty sterile (3.2.4.) ......................... 370

Containers of plasticised poly(vinyl chloride) for human bloodcontaining anticoagulant solution, sterile (3.2.5.) ................. 371

Contamination, microbial : microbial enumeration tests(2.6.12.) ............................................................................................ 163

Contamination, microbial : microbial enumeration tests (2.6.12.)(5.8.).................................................................................................. 622

Contamination, microbial : test for specified micro-organisms(2.6.13.) ............................................................................................ 167

Contamination, microbial : test for specified micro-organisms(2.6.13.) (5.8.) ................................................................................. 622

Content uniformity of single-dose preparations (2.9.6.).......... 266Control of impurities in substances for pharmaceutical use(5.10.)................................................................................................ 631

Control of microbiological quality, alternative methods for(5.1.6.)............................................................................................... 508

Copolymer, basic butylated methacrylate ................................1448Copolymer, grafted, macrogol poly(vinyl alcohol)..................2401Copolymer, methacrylic acid - ethyl acrylate (1:1) .................2459Copolymer, methacrylic acid - ethyl acrylate (1:1) dispersion30 per cent ....................................................................................2460

Copolymer (type A), ammonio methacrylate ........................... 1381Copolymer (type B), ammonio methacrylate ...........................1382Copovidone...................................................................................... 1764Copper acetate monohydrate for homoeopathic prepara-tions ................................................................................................1289

Copper for homoeopathic preparations....................................1289Copper sulfate, anhydrous ........................................................... 1766Copper sulfate pentahydrate ....................................................... 1766Coriander ......................................................................................... 1108Coriander oil ................................................................................... 1108Cortisone acetate ........................................................................... 1767Cotton, absorbent .......................................................................... 1768Cottonseed oil, hydrogenated .................................................... 1769Couch grass rhizome .................................................................... 1109Creams................................................................................................ 735Cresol, crude ...................................................................................1770Cromoglicate, sodium ...................................................................2923Croscarmellose sodium.................................................................1770Crospovidone .................................................................................. 1771Crotamiton ......................................................................................1773Crystalline and partially crystalline solids, characterisationby X-ray powder diffraction (XRPD) of (2.9.33.) ..................... 301

Cutaneous application, liquid preparations for......................... 717Cutaneous application, powders for ............................................ 726Cutaneous application, semi-solid preparations for ................. 734Cutaneous application, veterinary liquid preparations for..... 740Cutaneous foams.............................................................................. 717Cutaneous patches .......................................................................... 734Cyanocobalamin ............................................................................. 1774Cyanocobalamin (57Co) capsules .................................................. 967Cyanocobalamin (57Co) solution ................................................... 968Cyanocobalamin (58Co) capsules .................................................. 968Cyanocobalamin (58Co) solution ................................................... 969Cyclamate, sodium.........................................................................2924Cyclizine hydrochloride................................................................1775Cyclopentolate hydrochloride ..................................................... 1776Cyclophosphamide.........................................................................1777Cyproheptadine hydrochloride ...................................................1778Cyproterone acetate ......................................................................1779Cysteine hydrochloride monohydrate ....................................... 1781Cystine..............................................................................................1782Cytarabine .......................................................................................1783

DDacarbazine.....................................................................................1787Dalteparin sodium .........................................................................1788Danaparoid sodium .......................................................................1789Dandelion herb with root............................................................. 1110Dandelion root................................................................................ 1111Dapsone ...........................................................................................1792



Daunorubicin hydrochloride .......................................................1792D-Camphor .......................................................................................1569Decyl oleate .....................................................................................1794Deferoxamine mesilate..................................................................1794Degree of coloration of liquids (2.2.2.).......................................... 22Dembrexine hydrochloride monohydrate for veteri-nary use .........................................................................................1795

Demeclocycline hydrochloride....................................................1796Density of powders, bulk density and tapped (2.9.34.) ........... 305Density of solids (2.2.42.) ................................................................. 66Density of solids, gas pycnometric (2.9.23.)............................... 288Density, relative (2.2.5.) .................................................................... 25Dental type silica............................................................................2903Depressor substances (2.6.11.)...................................................... 162Deptropine citrate..........................................................................1797Dequalinium chloride....................................................................1798Desflurane .......................................................................................1800Desipramine hydrochloride ......................................................... 1801Deslanoside .....................................................................................1802Desmopressin..................................................................................1803Desogestrel ......................................................................................1804Desoxycortone acetate..................................................................1805Detector tubes, gas (2.1.6.) ...............................................................17Determination of aflatoxin B1 in herbal drugs (2.8.18.).......... 244Determination of essential oils in herbal drugs (2.8.12.)........ 241Determination of nitrogen by sulfuric acid digestion (2.5.9.) .. 139Determination of primary aromatic amino-nitrogen (2.5.8.) .. 139Determination of tannins in herbal drugs (2.8.14.).................. 243Determination of water by distillation (2.2.13.) ...........................31Detomidine hydrochloride for veterinary use .........................1806Devil’s claw dry extract................................................................. 1112Devil’s claw root ............................................................................. 1113Dexamethasone ..............................................................................1807Dexamethasone acetate................................................................1809Dexamethasone isonicotinate ..................................................... 1811Dexamethasone sodium phosphate ........................................... 1812Dexchlorpheniramine maleate .................................................... 1814Dexpanthenol.................................................................................. 1815Dextran 1 for injection.................................................................. 1816Dextran 40 for injection ............................................................... 1817Dextran 60 for injection ............................................................... 1818Dextran 70 for injection ............................................................... 1819Dextranomer ................................................................................... 1819Dextrans, molecular mass distribution in (2.2.39.) .................... 60Dextrin..............................................................................................1820Dextromethorphan hydrobromide ............................................. 1821Dextromoramide tartrate .............................................................1822Dextropropoxyphene hydrochloride..........................................1823Diazepam .........................................................................................1824Diazoxide .........................................................................................1825Dibrompropamidine diisetionate ................................................1826Dibutyl phthalate ...........................................................................1827Dichloromethane............................................................................2474Diclazuril for veterinary use........................................................1828Diclofenac potassium ....................................................................1829Diclofenac sodium .........................................................................1830Dicloxacillin sodium ...................................................................... 1831Dicycloverine hydrochloride........................................................1833Didanosine.......................................................................................1833Dienestrol ........................................................................................1835Diethylcarbamazine citrate ..........................................................1836Diethylene glycol and ethylene glycol in ethoxylated substances(2.4.30.) ............................................................................................ 132

Diethylene glycol monoethyl ether............................................1837Diethylene glycol palmitostearate..............................................1839Diethyl phthalate ...........................................................................1835Diethylstilbestrol ............................................................................1839Diffraction, laser light, particle size analysis by (2.9.31.) ....... 295Diflunisal..........................................................................................1840Digitalis leaf .................................................................................... 1114Digitoxin........................................................................................... 1841Digoxin .............................................................................................1842Dihydralazine sulfate, hydrated..................................................1844

Dihydrocodeine hydrogen tartrate.............................................1845Dihydroergocristine mesilate ......................................................1846Dihydroergotamine mesilate .......................................................1849Dihydroergotamine tartrate ........................................................1850Dihydrostreptomycin sulfate for veterinary use...................... 1851Dihydrotachysterol ........................................................................1853Diltiazem hydrochloride ...............................................................1855Dimenhydrinate..............................................................................1856Dimercaprol.....................................................................................1858Dimethylacetamide ........................................................................1859Dimethylaniline, N,N- (2.4.26.)...................................................... 128Dimethyl sulfoxide .........................................................................1858Dimeticone ......................................................................................1860Dimetindene maleate ....................................................................1860Dinoprostone ..................................................................................1863Dinoprost trometamol...................................................................1862Diosmin ............................................................................................1864Dioxan and ethylene oxide (2.4.25.) ............................................ 127Dip concentrates .............................................................................. 740Diphenhydramine hydrochloride................................................1866Diphenoxylate hydrochloride ......................................................1867Diphtheria and tetanus toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.) ................................................... 231

Diphtheria and tetanus vaccine (adsorbed) ............................... 751Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s)content)............................................................................................ 752

Diphtheria antitoxin ........................................................................ 949Diphtheria, tetanus and hepatitis B (rDNA) vaccine(adsorbed)........................................................................................ 753

Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed)......................................................................... 754

Diphtheria, tetanus and pertussis vaccine (adsorbed) ........... 755Diphtheria, tetanus and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .................................... 756

Diphtheria, tetanus, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ................ 758

Diphtheria, tetanus, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ..................................... 760

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed) ........................ 762

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ........................................................................ 763

Diphtheria, tetanus, pertussis (acellular, component), hepatitis B(rDNA), poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed)...................................................... 765

Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed)......................................................................... 768

Diphtheria, tetanus, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)......................................................................... 771

Diphtheria, tetanus, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ................ 772

Diphtheria vaccine (adsorbed) ...................................................... 774Diphtheria vaccine (adsorbed), assay of (2.7.6.) ........................ 209Diphtheria vaccine (adsorbed, reduced antigen content) ....... 776Dipivefrine hydrochloride ............................................................1867Dipotassium clorazepate ..............................................................1869Dipotassium phosphate ................................................................1870Diprophylline ..................................................................................1870Dipyridamole...................................................................................1871Dirithromycin..................................................................................1872Disintegration of suppositories and pessaries (2.9.2.) ............. 255Disintegration of tablets and capsules (2.9.1.) .......................... 253Disodium clodronate tetrahydrate .............................................1723Disodium edetate ........................................................................... 1874Disodium etidronate......................................................................1979Disodium pamidronate pentahydrate........................................2660Disodium phosphate, anhydrous................................................1875Disodium phosphate dihydrate...................................................1875Disodium phosphate dodecahydrate ......................................... 1876Disopyramide .................................................................................. 1876Disopyramide phosphate..............................................................1877



Dispersible tablets ........................................................................... 737Dissolution, apparent (2.9.43.)...................................................... 320Dissolution, intrinsic (2.9.29.) ....................................................... 294Dissolution test for lipophilic solid dosage forms (2.9.42.) .... 319Dissolution test for medicated chewing gums (2.9.25.) .......... 289Dissolution test for solid dosage forms (2.9.3.) ......................... 256Dissolution test for transdermal patches (2.9.4.)...................... 263Dissolution testing, recommendations on (5.17.1.) .................. 665Distemper vaccine (live), canine ................................................... 872Distemper vaccine (live) for mustelids ........................................ 887Distillation range (2.2.11.)................................................................ 30Distribution estimation by analytical sieving, particle-size(2.9.38.) ............................................................................................ 313

Distribution estimation by analytical sieving, particle-size(2.9.38.) (5.8.) ................................................................................. 623

Disulfiram ........................................................................................1878Dithranol..........................................................................................1879DL-Methionine .................................................................................2466DL-α-Tocopheryl hydrogen succinate......................................... 3110Dobesilate monohydrate, calcium .............................................. 1551Dobutamine hydrochloride..........................................................1880Docetaxel trihydrate...................................................................... 1881Docusate sodium............................................................................1883Dodecyl gallate ...............................................................................1884Dog rose ........................................................................................... 1115Domperidone ..................................................................................1885Domperidone maleate ...................................................................1886Dopamine hydrochloride..............................................................1887Dopexamine dihydrochloride ......................................................1889Dorzolamide hydrochloride .........................................................1890Dosage forms (glossary) ................................................................. 707Dosage units, uniformity of (2.9.40.) ........................................... 315Dosulepin hydrochloride..............................................................1892Doxapram hydrochloride..............................................................1893Doxazosin mesilate ........................................................................1894Doxepin hydrochloride .................................................................1895Doxorubicin hydrochloride..........................................................1897Doxycycline hyclate .......................................................................1898Doxycycline monohydrate............................................................1899Doxylamine hydrogen succinate................................................. 1901Droperidol........................................................................................1902Droppers (2.1.1.)................................................................................. 15Drop point (2.2.17.)............................................................................ 32Drops (nasal) and sprays (liquid nasal) ....................................... 720Drops, oral ......................................................................................... 719Drospirenone ..................................................................................1903Dry extracts ....................................................................................... 676Dry residue of extracts (2.8.16.).................................................... 244Duck plague vaccine (live) ............................................................. 888Duck viral hepatitis type I vaccine (live)..................................... 889Dwarf pine oil ................................................................................. 1116Dydrogesterone ..............................................................................1905

EEar drops and ear sprays................................................................ 710Ear powders ...................................................................................... 710Ear preparations............................................................................... 709Ear preparations, semi-solid .......................................................... 710Ear sprays and ear drops................................................................ 710Ear tampons...................................................................................... 710Ear washes......................................................................................... 710Ebastine ...........................................................................................1909Econazole ........................................................................................ 1910Econazole nitrate ........................................................................... 1911Edetate, disodium .......................................................................... 1874Edetate, sodium calcium .............................................................. 2916Edetic acid ....................................................................................... 1912Edrophonium chloride.................................................................. 1913Effervescent granules...................................................................... 714Effervescent powders ...................................................................... 727Effervescent tablets ......................................................................... 737Efficacy of antimicrobial preservation (5.1.3.) ........................... 505

Efficacy of veterinary vaccines and immunosera, evaluation of(5.2.7.)............................................................................................... 538

Egg drop syndrome ′76 vaccine (inactivated)............................ 891Elder flower..................................................................................... 1117Electrophoresis (2.2.31.) ................................................................... 46Electrophoresis (2.2.31.) (5.8.) ...................................................... 621Electrophoresis, capillary (2.2.47.) ................................................. 77Electrophoresis, capillary (2.2.47.) (5.8.) .................................... 621Eleutherococcus............................................................................. 1118Emedastine difumarate................................................................. 1913Emetine hydrochloride heptahydrate........................................ 1914Emetine hydrochloride pentahydrate........................................ 1915Empty sterile containers of plasticised poly(vinyl chloride) forhuman blood and blood components (3.2.4.).......................... 370

Emulsifying cetostearyl alcohol (type A) ..................................1643Emulsifying cetostearyl alcohol (type B)..................................1645Emulsions, solutions and suspensions, oral .............................. 718Enalaprilat dihydrate .................................................................... 1918Enalapril maleate ........................................................................... 1916Encephalitis vaccine (inactivated), tick-borne ........................... 834Endotoxins, bacterial (2.6.14.)....................................................... 171Endotoxins, bacterial, guidelines for using the test for(5.1.10.) ............................................................................................ 520

Enilconazole for veterinary use.................................................. 1919Enoxaparin sodium........................................................................1920Enoxolone........................................................................................ 1921Enrofloxacin for veterinary use ..................................................1922Entacapone......................................................................................1924Enzootic pneumonia vaccine (inactivated), porcine................. 927Ephedra herb ..................................................................................1120Ephedrine, anhydrous...................................................................1925Ephedrine hemihydrate ................................................................1926Ephedrine hydrochloride .............................................................1927Ephedrine hydrochloride, racemic.............................................1928Epinastine hydrochloride .............................................................1928Epinephrine.....................................................................................1329Epinephrine tartrate .....................................................................1330Epirubicin hydrochloride .............................................................1929Equine herpesvirus vaccine (inactivated) ................................... 892Equine influenza vaccine (inactivated) ....................................... 893Equisetum stem.............................................................................. 1121Ergocalciferol.................................................................................. 1931Ergometrine maleate.....................................................................1933Ergotamine tartrate.......................................................................1934Erysipelas vaccine (inactivated), swine ....................................... 939Erythritol .........................................................................................1935Erythromycin ..................................................................................1936Erythromycin estolate...................................................................1938Erythromycin ethylsuccinate.......................................................1940Erythromycin lactobionate ..........................................................1942Erythromycin stearate ..................................................................1944Erythropoietin concentrated solution.......................................1946Eserine salicylate ...........................................................................2726Eserine sulfate ................................................................................2727Esketamine hydrochloride ...........................................................1950Esomeprazole magnesium trihydrate........................................ 1951Essential oils ..................................................................................... 673Essential oils, assay of 1,8-cineole in (2.8.11.) ........................... 240Essential oils, fatty oils and resinified essential oils in(2.8.7.)............................................................................................... 239

Essential oils, foreign esters in (2.8.6.) ....................................... 239Essential oils in herbal drugs, determination of (2.8.12.)....... 241Essential oils, odour and taste (2.8.8.) ........................................ 240Essential oils, residue on evaporation (2.8.9.) ........................... 240Essential oils, solubility in alcohol (2.8.10.)............................... 240Essential oils, water in (2.8.5.) ...................................................... 239Ester value (2.5.2.) ........................................................................... 137Estradiol benzoate .........................................................................1953Estradiol hemihydrate...................................................................1954Estradiol valerate ...........................................................................1955Estriol ...............................................................................................1956Estrogens, conjugated ..................................................................1958Etacrynic acid .................................................................................1960



Etamsylate ....................................................................................... 1961Ethacridine lactate monohydrate...............................................1962Ethambutol hydrochloride...........................................................1963Ethanol (96 per cent) ....................................................................1964Ethanol, anhydrous .......................................................................1966Ethanol content and alcoholimetric tables (2.9.10.) ................ 268Ether .................................................................................................1968Ether, anaesthetic ..........................................................................1968Ethinylestradiol ..............................................................................1969Ethionamide....................................................................................1970Ethosuximide ..................................................................................1971Ethoxylated substances, ethylene glycol and diethylene glycolin (2.4.30.) ....................................................................................... 132

Ethyl acetate ...................................................................................1972Ethyl acrylate - methacrylic acid copolymer (1:1) ..................2459Ethyl acrylate - methacrylic acid copolymer (1:1) dispersion30 per cent ....................................................................................2460

Ethylcellulose .................................................................................1975Ethylenediamine ............................................................................1977Ethylene glycol and diethylene glycol in ethoxylated substances(2.4.30.) ............................................................................................ 132

Ethylene glycol monopalmitostearate....................................... 1976Ethylene glycol monostearate..................................................... 1976Ethylene oxide and dioxan (2.4.25.) ............................................ 127Ethylhexanoic acid, 2- (2.4.28.) ..................................................... 130Ethylmorphine hydrochloride.....................................................1978Ethyl oleate .....................................................................................1973Ethyl parahydroxybenzoate.........................................................1973Ethyl parahydroxybenzoate sodium .......................................... 1974Etidronate disodium......................................................................1979Etilefrine hydrochloride ...............................................................1979Etodolac ........................................................................................... 1981Etofenamate ....................................................................................1982Etofylline..........................................................................................1984Etomidate ........................................................................................1985Etoposide .........................................................................................1986Eucalyptus leaf ...............................................................................1122Eucalyptus oil .................................................................................1123Eugenol ............................................................................................1990European goldenrod ..................................................................... 1142European viper venom antiserum................................................ 953Evaluation of efficacy of veterinary vaccines and immunosera(5.2.7.)............................................................................................... 538

Evaluation of safety of each batch of veterinary vaccines andimmunosera (5.2.9.) ...................................................................... 547

Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) .............................................................................................. 536

Evening primrose oil, refined...................................................... 1991Extractable volume of parenteral preparations, test for(2.9.17.)............................................................................................. 273

Extractable volume of parenteral preparations, test for (2.9.17.)(5.8.).................................................................................................. 622

Extracts .............................................................................................. 674Extracts, dry ...................................................................................... 676Extracts, dry residue of (2.8.16.)................................................... 244Extracts, liquid.................................................................................. 675Extracts, loss on drying of (2.8.17.).............................................. 244Extracts, soft ..................................................................................... 676Extraneous agents in viral vaccines for human use, tests for(2.6.16.) ............................................................................................ 176

Extraneous agents : tests in batches of finished product of avianlive virus vaccines (2.6.25.).......................................................... 188

Extraneous agents : tests in seed lots of avian viral vaccines(2.6.24.) ............................................................................................ 185

Eye drops ........................................................................................... 711Eye lotions......................................................................................... 711Eye preparations .............................................................................. 710Eye preparations, semi-solid .......................................................... 712

FF0 concept to steam sterilisation of aqueous preparations,application of (5.1.5.) .................................................................... 508

Factor II, human coagulation, assay of (2.7.18.) ....................... 224Factor IX, human coagulation .................................................... 2172Factor IX, human coagulation, assay of (2.7.11.) ...................... 219Factor VII, human coagulation................................................... 2169Factor VII, human coagulation, assay of (2.7.10.) .................... 219Factor VIII, human coagulation ................................................. 2170Factor VIII, human coagulation, assay of (2.7.4.) ..................... 207Factor VIII (rDNA), human coagulation ................................... 2171Factor X, human coagulation, assay of (2.7.19.) ....................... 225Factor XI, human coagulation .................................................... 2173Factor XI, human coagulation, assay of (2.7.22.)...................... 227Falling ball viscometer method (2.2.49.) ...................................... 83Famotidine.......................................................................................1995Fat, hard........................................................................................... 2146Fatty acids, composition by gas chromatography (2.4.22.) .... 119Fatty acids in oils rich in omega-3 acids, composition of(2.4.29.) ............................................................................................ 130

Fatty oils, alkaline impurities in (2.4.19.) ................................... 119Fatty oils and herbal drugs, heavy metals in (2.4.27.) ............. 129Fatty oils and resinified essential oils in essential oils(2.8.7.)............................................................................................... 239

Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) ............................................................................................ 119

Fatty oils, identification by thin-layer chromatography(2.3.2.) .............................................................................................. 110

Fatty oils, sterols in (2.4.23.) ......................................................... 121Fatty oils, vegetable......................................................................... 703Fc function of immunoglobulin, test for (2.7.9.) ........................217Febantel for veterinary use..........................................................1996Felbinac ............................................................................................1997Feline calicivirosis vaccine (inactivated) ..................................... 895Feline calicivirosis vaccine (live)................................................... 896Feline chlamydiosis vaccine (inactivated)................................... 897Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) .................................................................................... 898

Feline infectious enteritis (feline panleucopenia) vaccine(live) .................................................................................................. 899

Feline leukaemia vaccine (inactivated)........................................ 900Feline panleucopenia vaccine (inactivated)................................ 898Feline panleucopenia vaccine (live) ............................................. 899Feline viral rhinotracheitis vaccine (inactivated) ...................... 901Feline viral rhinotracheitis vaccine (live).................................... 902Felodipine ........................................................................................1998Felypressin.......................................................................................1999Fenbendazole for veterinary use ................................................2000Fenbufen ..........................................................................................2001Fennel, bitter...................................................................................1124Fennel, sweet...................................................................................1125Fenofibrate ......................................................................................2002Fenoterol hydrobromide...............................................................2003Fentanyl ...........................................................................................2005Fentanyl citrate...............................................................................2006Fenticonazole nitrate ....................................................................2007Fenugreek........................................................................................1126Fermentation, products of ............................................................. 685Ferric chloride hexahydrate ........................................................2008Ferrous fumarate ...........................................................................2009Ferrous gluconate.......................................................................... 2010Ferrous sulfate, dried .................................................................... 2011Ferrous sulfate heptahydrate ...................................................... 2012Feverfew ...........................................................................................1126Fexofenadine hydrochloride ........................................................ 2013Fibrinogen, human ........................................................................ 2174Fibrin sealant kit ............................................................................ 2014Filgrastim concentrated solution ............................................... 2015Finasteride....................................................................................... 2018Fineness, powder (2.9.35.) ............................................................. 308Fish oil, rich in omega-3 acids..................................................... 2019Flavoxate hydrochloride ...............................................................2021Flecainide acetate ..........................................................................2022Flocculation value (Lf) of diphtheria and tetanus toxins andtoxoids (Ramon assay) (2.7.27.) .................................................. 231

Flowability (2.9.16.) ......................................................................... 272



Flow cytometry (2.7.24.) ................................................................. 229Flubendazole ..................................................................................2024Flucloxacillin magnesium octahydrate .....................................2025Flucloxacillin sodium ....................................................................2026Fluconazole .....................................................................................2028Flucytosine ......................................................................................2029Fludarabine phosphate.................................................................2031Fludeoxyglucose (18F) injection .................................................... 969Fludrocortisone acetate................................................................2033Flumazenil .......................................................................................2035Flumazenil (N-[11C]methyl) injection ........................................... 972Flumequine .....................................................................................2036Flumetasone pivalate ....................................................................2037Flunarizine dihydrochloride........................................................2038Flunitrazepam.................................................................................2039Flunixin meglumine for veterinary use.....................................2040Fluocinolone acetonide ................................................................2041Fluocortolone pivalate..................................................................2042Fluorescein ......................................................................................2044Fluorescein sodium .......................................................................2045Fluoride (18F) solution for radiolabelling.................................... 973Fluorides (2.4.5.) ...............................................................................114Fluorimetry (2.2.21.) ......................................................................... 35Fluorodopa (18F) (prepared by electrophilic substitution)injection ........................................................................................... 974

Fluorouracil.....................................................................................2046Fluoxetine hydrochloride .............................................................2048Flupentixol dihydrochloride ........................................................2049Fluphenazine decanoate ..............................................................2051Fluphenazine dihydrochloride....................................................2052Fluphenazine enantate .................................................................2054Flurazepam monohydrochloride ................................................2055Flurbiprofen ....................................................................................2056Fluspirilene .....................................................................................2057Flutamide.........................................................................................2058Fluticasone propionate .................................................................2059Flutrimazole ....................................................................................2061Fluvastatin sodium ........................................................................2062Fluvoxamine maleate ....................................................................2063Foams, cutaneous ............................................................................ 717Foams, intrauterine ......................................................................... 715Foams, medicated ............................................................................ 712Foams, rectal ..................................................................................... 733Foams, vaginal .................................................................................. 740Folic acid..........................................................................................2065Folinate, calcium ............................................................................1552Foot-and-mouth disease (ruminants) vaccine (inactivated) .... 904Foreign esters in essential oils (2.8.6.) ........................................ 239Foreign matter (2.8.2.) .................................................................... 239Foreign oils in fatty oils by thin-layer chromatography(2.4.21.) ............................................................................................ 119

Formaldehyde, free (2.4.18.) .......................................................... 118Formaldehyde solution (35 per cent) ........................................2066Formoterol fumarate dihydrate ..................................................2067Foscarnet sodium hexahydrate...................................................2069Fosfomycin calcium .......................................................................2070Fosfomycin sodium........................................................................2071Fosfomycin trometamol ................................................................2072Fosinopril sodium ..........................................................................2073Fourstamen stephania root..........................................................1127Fowl cholera vaccine (inactivated) ............................................... 905Fowl-pox vaccine (live) .................................................................... 906Framycetin sulfate .........................................................................2076Frangula bark .................................................................................1128Frangula bark dry extract, standardised ..................................1129Frankincense, Indian .................................................................... 1152Free formaldehyde (2.4.18.) ........................................................... 118Freezing point (2.2.18.) .................................................................... 34Fresh bilberry fruit dry extract, refined and standardised ...1130Friability of granules and spheroids (2.9.41.) ............................ 318Friability of uncoated tablets (2.9.7.)........................................... 266Friability of uncoated tablets (2.9.7.) (5.8.) ................................ 622Fructose ...........................................................................................2077

Fucus ................................................................................................ 1161Fumitory .......................................................................................... 1132Functional groups and ions, identification reactions of(2.3.1.)............................................................................................... 107

Furosemide......................................................................................2078Furunculosis vaccine (inactivated, oil-adjuvanted, injectable) forsalmonids......................................................................................... 907

Fusidate, sodium............................................................................2926Fusidic acid .....................................................................................2079

GGalactose..........................................................................................2083Galantamine hydrobromide .........................................................2083Gallium (67Ga) citrate injection ..................................................... 975Ganciclovir.......................................................................................2086Gargles................................................................................................ 722Garlic for homoeopathic preparations ......................................1290Garlic powder.................................................................................. 1133Gas adsorption, specific surface area by (2.9.26.)..................... 291Gas adsorption, specific surface area by (2.9.26.) (5.8.).......... 622Gas chromatography (2.2.28.) ......................................................... 43Gas detector tubes (2.1.6.) ................................................................17Gases, carbon dioxide in (2.5.24.)................................................. 143Gases, carbon monoxide in (2.5.25.) ............................................ 144Gases, nitrogen monoxide and nitrogen dioxide in (2.5.26.).. 145Gases, nitrous oxide in (2.5.35.).................................................... 150Gases, oxygen in (2.5.27.) ............................................................... 145Gases, water in (2.5.28.).................................................................. 145Gas-gangrene antitoxin, mixed ...................................................... 950Gas-gangrene antitoxin (novyi) ..................................................... 950Gas-gangrene antitoxin (perfringens) .......................................... 951Gas-gangrene antitoxin (septicum)............................................... 952Gas pycnometric density of solids (2.9.23.) ................................ 288Gastro-resistant capsules ................................................................ 708Gastro-resistant granules................................................................ 714Gastro-resistant tablets ................................................................... 738Gelatin ..............................................................................................2087Gels...................................................................................................... 735Gels for injections ............................................................................ 725Gemcitabine hydrochloride..........................................................2088Gemfibrozil ......................................................................................2090General notices (1.)...............................................................................3General texts on biological products (5.2.) ................................ 527General texts on microbiology (5.1.)............................................ 503Gene transfer medicinal products for human use (5.14.)........ 647Gentamicin sulfate .........................................................................2091Gentian root .................................................................................... 1133Gentian tincture ............................................................................. 1134Gestodene ........................................................................................2092Ginger ............................................................................................... 1135Gingival solutions ............................................................................ 722Ginkgo dry extract, refined and quantified.............................. 1136Ginkgo leaf ...................................................................................... 1138Ginseng............................................................................................. 1140Glass containers for pharmaceutical use (3.2.1.) ...................... 363Glibenclamide .................................................................................2094Gliclazide..........................................................................................2096Glimepiride ......................................................................................2097Glipizide ...........................................................................................2098Glossary (dosage forms) ................................................................. 707Glucagon, human........................................................................... 2100Glucoheptonate, calcium..............................................................1554Glucose, anhydrous ....................................................................... 2102Glucose, liquid ................................................................................ 2103Glucose, liquid, spray-dried.......................................................... 2103Glucose monohydrate ................................................................... 2104Glutamic acid .................................................................................. 2105Glutathione...................................................................................... 2106Glycan analysis of glycoproteins (2.2.59.)..................................... 97Glycerol ............................................................................................ 2108Glycerol (85 per cent).................................................................... 2109Glycerol dibehenate ....................................................................... 2110



Glycerol distearate ......................................................................... 2111Glycerol monocaprylate................................................................ 2112Glycerol monocaprylocaprate...................................................... 2113Glycerol monolinoleate ................................................................. 2114Glycerol mono-oleate..................................................................... 2115Glycerol monostearate 40-55....................................................... 2116Glycerol triacetate.......................................................................... 3127Glyceryl trinitrate solution........................................................... 2117Glycine .............................................................................................. 2118Glycoproteins, glycan analysis of (2.2.59.).................................... 97Glycyrrhizate ammonium.............................................................1384Goldenrod ........................................................................................ 1141Goldenrod, European.................................................................... 1142Goldenseal rhizome....................................................................... 1143Gonadorelin acetate ...................................................................... 2119Gonadotrophin, chorionic ............................................................2120Gonadotrophin, equine serum, for veterinary use.................. 2121Goserelin .......................................................................................... 2121Grafted copolymer, macrogol poly(vinyl alcohol) ...................2401Gramicidin .......................................................................................2123Granisetron hydrochloride...........................................................2124Granules ............................................................................................. 713Granules and powders for oral solutions and suspensions .... 718Granules and powders for syrups................................................. 719Granules and spheroids, friability of (2.9.41.)............................ 318Granules, coated............................................................................... 714Granules, effervescent..................................................................... 714Granules, gastro-resistant............................................................... 714Granules, modified-release............................................................. 714Greater celandine ........................................................................... 1145Griseofulvin .....................................................................................2126Guaiacol ...........................................................................................2127Guaifenesin......................................................................................2128Guanethidine monosulfate...........................................................2129Guar .................................................................................................. 1146Guar galactomannan ..................................................................... 2130Guidelines for using the test for bacterial endotoxins(5.1.10.) ............................................................................................ 520

Guidelines for using the test for sterility (5.1.9.) ...................... 519

HHaematopoietic products, numeration of CD34/CD45+ cells in(2.7.23.) ............................................................................................ 228

Haematopoietic progenitor cells, human, colony-forming cellassay for (2.7.28.) ........................................................................... 232

Haematopoietic stem cells, human ............................................ 2175Haemodiafiltration and haemofiltration, solutions for.......... 2138Haemodialysis, concentrated solutions for .............................. 2136Haemodialysis solutions, concentrated, water for diluting ..2135Haemodialysis, solutions for........................................................ 2136Haemofiltration and haemodiafiltration, solutions for.......... 2138Haemophilus type b (conjugate), diphtheria, tetanus andpertussis (acellular, component) vaccine (adsorbed)............. 758

Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component) and poliomyelitis (inactivated) vaccine(adsorbed)........................................................................................ 768

Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and poliomyelitis(inactivated) vaccine (adsorbed) ................................................. 765

Haemophilus type b (conjugate), diphtheria, tetanus, pertussisand poliomyelitis (inactivated) vaccine (adsorbed) ................ 772

Haemophilus type b conjugate vaccine....................................... 776Haemorrhagic disease vaccine (inactivated), rabbit ................. 933Halofantrine hydrochloride ......................................................... 2141Haloperidol...................................................................................... 2142Haloperidol decanoate.................................................................. 2143Halothane ........................................................................................ 2144Hamamelis leaf ............................................................................... 1146Hard capsules.................................................................................... 708Hard fat ............................................................................................ 2146Hard paraffin...................................................................................2668Harmonisation, pharmacopoeial (5.8.) ........................................ 621

Hawthorn berries ........................................................................... 1147Hawthorn leaf and flower ............................................................ 1148Hawthorn leaf and flower dry extract ....................................... 1149Hawthorn leaf and flower liquid extract, quantified.............. 1150Heavy bismuth subnitrate ............................................................1498Heavy kaolin.................................................................................... 2314Heavy magnesium carbonate ......................................................2409Heavy magnesium oxide............................................................... 2415Heavy metals (2.4.8.) ........................................................................114Heavy metals in herbal drugs and fatty oils (2.4.27.)............... 129Hedera helix for homoeopathic preparations.......................... 1291Helium .............................................................................................. 2146Heparin, assay of (2.7.5.) ................................................................ 208Heparin calcium ............................................................................. 2147Heparin in coagulation factors, assay of (2.7.12.)..................... 220Heparins, low-molecular-mass ..................................................... 2151Heparin sodium.............................................................................. 2149Hepatitis A immunoglobulin, human ........................................ 2176Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed)........................................................................................ 779

Hepatitis A vaccine, assay of (2.7.14.) .......................................... 222Hepatitis A vaccine (inactivated, adsorbed) ............................... 780Hepatitis A vaccine (inactivated, virosome) ............................... 781Hepatitis B immunoglobulin for intravenous administration,human ............................................................................................ 2176

Hepatitis B immunoglobulin, human ........................................ 2176Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed)........................................................................................ 753

Hepatitis B (rDNA), diphtheria, tetanus and pertussis (acellular,component) vaccine (adsorbed).................................................. 760

Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) ......................................... 765

Hepatitis B vaccine (rDNA)............................................................ 784Hepatitis B vaccine (rDNA), assay of (2.7.15.) ........................... 223Hepatitis C virus (HCV), validation of nucleic acid amplificationtechniques for the detection of HCV RNA in plasma pools :guidelines ........................................................................................ 181

Heptaminol hydrochloride ........................................................... 2153Herbal drug preparations............................................................... 676Herbal drugs ..................................................................................... 676Herbal drugs and fatty oils, heavy metals in (2.4.27.).............. 129Herbal drugs, determination of aflatoxin B1 in (2.8.18.)......... 244Herbal drugs, determination of essential oils in herbal drugs(2.8.12.) ............................................................................................ 241

Herbal drugs, determination of tannins (2.8.14.) ..................... 243Herbal drugs for homoeopathic preparations .........................1275Herbal drugs, microscopic examination of (2.8.23) ................. 250Herbal drugs : sampling and sample preparation (2.8.20.) ..... 246Herbal drugs, test for aristolochic acids in (2.8.21) ................. 247Herbal medicinal products for oral use, microbial examination(2.6.31.) ............................................................................................ 197

Herbal medicinal products for oral use, microbiological quality(5.1.8.)............................................................................................... 519

Herbal preparations......................................................................... 676Herbal substances............................................................................ 676Herbal teas......................................................................................... 677Herpes zoster (shingles) vaccine (live) ........................................ 828Hexamidine diisetionate ............................................................... 2154Hexetidine........................................................................................ 2155Hexobarbital.................................................................................... 2156Hexosamines in polysaccharide vaccines (2.5.20.) ................... 142Hexylresorcinol............................................................................... 2157Highly purified water ....................................................................3222Histamine (2.6.10.)........................................................................... 162Histamine dihydrochloride .......................................................... 2158Histamine phosphate .................................................................... 2159Histidine........................................................................................... 2159Histidine hydrochloride monohydrate ...................................... 2160Homatropine hydrobromide ........................................................ 2161Homatropine methylbromide ...................................................... 2162Homoeopathic preparations ........................................................1275Homoeopathic preparations, arsenious trioxide for ..............1286



Homoeopathic preparations, calcium iodide tetrahydratefor ....................................................................................................1288

Homoeopathic preparations, common stinging nettle for....1288Homoeopathic preparations, copper acetate monohydratefor ....................................................................................................1289

Homoeopathic preparations, copper for...................................1289Homoeopathic preparations, garlic for .....................................1290Homoeopathic preparations, hedera helix for......................... 1291Homoeopathic preparations, herbal drugs for ........................1275Homoeopathic preparations, honey bee for.............................1292Homoeopathic preparations, hyoscyamus for .........................1292Homoeopathic preparations, hypericum for ............................1293Homoeopathic preparations, iron for ........................................1294Homoeopathic preparations, mother tinctures for.................1286Homoeopathic preparations, oriental cashew for...................1295Homoeopathic preparations, saffron for...................................1296Homoeopathic stocks (methods of preparation of) andpotentisation.................................................................................1277

Honey ............................................................................................... 2163Honey bee for homoeopathic preparations..............................1292Hop strobile..................................................................................... 1151Human α-1-proteinase inhibitor ................................................. 2184Human albumin injection, iodinated (125I).................................. 976Human albumin solution ............................................................. 2165Human anti-D immunoglobulin .................................................. 2166Human anti-D immunoglobulin, assay of (2.7.13.) ................... 220Human anti-D immunoglobulin for intravenousadministration .............................................................................. 2167

Human antithrombin III, assay of (2.7.17.) ................................. 224Human antithrombin III concentrate ........................................ 2168Human coagulation factor II, assay of (2.7.18.)......................... 224Human coagulation factor IX...................................................... 2172Human coagulation factor IX, assay of (2.7.11.)........................ 219Human coagulation factor VII .................................................... 2169Human coagulation factor VII, assay of (2.7.10.) ...................... 219Human coagulation factor VIII................................................... 2170Human coagulation factor VIII, assay of (2.7.4.)....................... 207Human coagulation factor VIII (rDNA)..................................... 2171Human coagulation factor X, assay of (2.7.19.) ......................... 225Human coagulation factor XI...................................................... 2173Human coagulation factor XI, assay of (2.7.22.) ....................... 227Human fibrinogen.......................................................................... 2174Human haematopoietic progenitor cells, colony-forming cellassay for (2.7.28.) ........................................................................... 232

Human haematopoietic stem cells ............................................. 2175Human hepatitis A immunoglobulin ......................................... 2176Human hepatitis B immunoglobulin ......................................... 2176Human hepatitis B immunoglobulin for intravenousadministration .............................................................................. 2176

Human insulin ................................................................................2241Human measles immunoglobulin............................................... 2177Human normal immunoglobulin................................................ 2177Human normal immunoglobulin for intravenousadministration .............................................................................. 2179

Human papillomavirus vaccine (rDNA) ...................................... 785Human plasma for fractionation................................................. 2181Human plasma (pooled and treated for virus inactivation) .. 2182Human plasmin inhibitor, assay of (2.7.25.)............................... 230Human protein C, assay of (2.7.30.) ............................................. 234Human protein S, assay of (2.7.31.) ............................................. 235Human prothrombin complex..................................................... 2185Human rabies immunoglobulin .................................................. 2186Human rubella immunoglobulin ................................................ 2187Human tetanus immunoglobulin ............................................... 2187Human varicella immunoglobulin.............................................. 2188Human varicella immunoglobulin for intravenousadministration .............................................................................. 2189

Human von Willebrand factor..................................................... 2189Human von Willebrand factor, assay of (2.7.21.) ...................... 226Hyaluronate, sodium.....................................................................2927Hyaluronidase ................................................................................ 2190Hydralazine hydrochloride .......................................................... 2191Hydrochloric acid, concentrated ................................................ 2192

Hydrochloric acid, dilute .............................................................. 2192Hydrochlorothiazide...................................................................... 2193Hydrocodone hydrogen tartrate 2.5-hydrate ........................... 2194Hydrocortisone............................................................................... 2196Hydrocortisone acetate................................................................. 2198Hydrocortisone hydrogen succinate ..........................................2200Hydrogenated arachis oil ............................................................. 1413Hydrogenated castor oil ...............................................................1596Hydrogenated cottonseed oil ...................................................... 1769Hydrogenated soya-bean oil.........................................................2968Hydrogenated vegetable oils, nickel in (2.4.31.)........................ 132Hydrogenated wool fat..................................................................3232Hydrogen peroxide solution (30 per cent) ...............................2202Hydrogen peroxide solution (3 per cent)..................................2201Hydromorphone hydrochloride ..................................................2202Hydrophobic colloidal silica ........................................................2903Hydrous wool fat ............................................................................3233Hydroxocobalamin acetate...........................................................2203Hydroxocobalamin chloride.........................................................2204Hydroxocobalamin sulfate ...........................................................2205Hydroxycarbamide .........................................................................2206Hydroxyethylcellulose...................................................................2208Hydroxyethylmethylcellulose ......................................................2476Hydroxyethyl salicylate.................................................................2207Hydroxyethyl starches...................................................................2984Hydroxyl value (2.5.3.) .................................................................... 137Hydroxypropylbetadex.................................................................. 2210Hydroxypropylcellulose ................................................................ 2211Hydroxypropylmethylcellulose.................................................... 2219Hydroxypropylmethylcellulose phthalate.................................2221Hydroxypropyl starch....................................................................2981Hydroxyzine hydrochloride .........................................................2212Hymecromone................................................................................. 2213Hyoscine........................................................................................... 2214Hyoscine butylbromide ................................................................. 2215Hyoscine hydrobromide................................................................ 2216Hyoscyamine sulfate...................................................................... 2217Hyoscyamus for homoeopathic preparations ..........................1292Hypericum .......................................................................................1241Hypericum for homoeopathic preparations.............................1293Hypromellose .................................................................................. 2219Hypromellose phthalate ...............................................................2221

IIbuprofen .........................................................................................2225Iceland moss.................................................................................... 1152ICH (5.8.)............................................................................................ 621Ichthammol .....................................................................................2227Identification (2.3.) .......................................................................... 107Identification and control of residual solvents (2.4.24.).......... 123Identification of fatty oils by thin-layer chromatography(2.3.2.) .............................................................................................. 110

Identification of phenothiazines by thin-layer chromatography(2.3.3.) .............................................................................................. 110

Identification reactions of ions and functional groups(2.3.1.)............................................................................................... 107

Idoxuridine ......................................................................................2227Ifosfamide ........................................................................................2228Imipenem .........................................................................................2230Imipramine hydrochloride ...........................................................2231Immunochemical methods (2.7.1.) ............................................... 201Immunoglobulin for human use, anti-T lymphocyte,animal.............................................................................................1404

Immunoglobulin for intravenous administration, humananti-D .............................................................................................. 2167

Immunoglobulin for intravenous administration, humanhepatitis B ..................................................................................... 2176

Immunoglobulin for intravenous administration, humannormal ............................................................................................ 2179

Immunoglobulin for intravenous administration, humanvaricella.......................................................................................... 2189

Immunoglobulin, human anti-D ................................................. 2166



Immunoglobulin, human anti-D, assay of (2.7.13.) ................... 220Immunoglobulin, human hepatitis A......................................... 2176Immunoglobulin, human hepatitis B ........................................ 2176Immunoglobulin, human measles .............................................. 2177Immunoglobulin, human normal ............................................... 2177Immunoglobulin, human rabies ................................................. 2186Immunoglobulin, human rubella ............................................... 2187Immunoglobulin, human tetanus............................................... 2187Immunoglobulin, human varicella ............................................. 2188Immunoglobulin, test for anticomplementary activity of(2.6.17.)............................................................................................. 177

Immunoglobulin, test for Fc function of (2.7.9.)........................217Immunological veterinary medicinal products, substances ofanimal origin for the production of (5.2.5.) ............................. 535

Immunosera and vaccines, phenol in (2.5.15.) ...........................141Immunosera and vaccines, veterinary, evaluation of efficacy of(5.2.7.)............................................................................................... 538

Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) .............................................................................................. 536

Immunosera and vaccines, veterinary, evaluation of the safetyof each batch (5.2.9.)..................................................................... 547

Immunosera for human use, animal............................................ 678Immunosera for veterinary use..................................................... 680Implants ............................................................................................. 725Impurities in substances for pharmaceutical use, control of(5.10.)................................................................................................ 631

Indapamide......................................................................................2232Indian frankincense....................................................................... 1152Indicators, relationship between approximate pH and colour(2.2.4.) ................................................................................................ 25

Indinavir sulfate .............................................................................2233Indium (111In) chloride solution .................................................... 977Indium (111In) oxine solution ......................................................... 978Indium (111In) pentetate injection................................................. 979Indometacin ....................................................................................2235Inductively coupled plasma-atomic emission spectrometry(2.2.57.) .............................................................................................. 94

Inductively coupled plasma-mass spectrometry (2.2.58.).......... 96Infectious bovine rhinotracheitis vaccine (live)......................... 908Infectious bronchitis vaccine (inactivated), avian ..................... 851Infectious bronchitis vaccine (live), avian................................... 852Infectious bursal disease vaccine (inactivated), avian.............. 854Infectious bursal disease vaccine (live), avian ........................... 856Infectious chicken anaemia vaccine (live) .................................. 910Infectious encephalomyelitis vaccine (live), avian .................... 857Infectious laryngotracheitis vaccine (live), avian ...................... 859Influenza vaccine (split virion, inactivated) ............................... 788Influenza vaccine (surface antigen, inactivated)....................... 789Influenza vaccine (surface antigen, inactivated, prepared in cellcultures) ........................................................................................... 791

Influenza vaccine (surface antigen, inactivated, virosome).... 793Influenza vaccine (whole virion, inactivated) ............................ 795Influenza vaccine (whole virion, inactivated, prepared in cellcultures) ........................................................................................... 796

Infrared absorption spectrophotometry (2.2.24.) ....................... 38Infusions ............................................................................................ 725Inhalation gas, krypton (81mKr) ..................................................... 983Inhalation, preparations for........................................................... 728Inhalation, preparations for : aerodynamic assessment of fineparticles (2.9.18.) ........................................................................... 274

Injectable insulin preparations ...................................................2249Injections ........................................................................................... 724Injections, gels for............................................................................ 725Injections or infusions, concentrates for .................................... 725Injections or infusions, powders for ............................................ 725Inositol, myo- ..................................................................................2236Inserts, ophthalmic.......................................................................... 712Insulin aspart ..................................................................................2237Insulin, bovine ................................................................................2239Insulin, human................................................................................2241Insulin injection, biphasic ............................................................2243Insulin injection, biphasic isophane ..........................................2244Insulin injection, isophane...........................................................2244

Insulin injection, soluble ..............................................................2244Insulin lispro ...................................................................................2245Insulin, porcine...............................................................................2247Insulin preparations, injectable ..................................................2249Insulin zinc injectable suspension .............................................2251Insulin zinc injectable suspension (amorphous) ....................2252Insulin zinc injectable suspension (crystalline) ......................2252Interferon alfa-2 concentrated solution ....................................2252Interferon beta-1a concentrated solution.................................2255Interferon gamma-1b concentrated solution ...........................2257Interferons, assay of (5.6.) .............................................................. 607International System (SI) units (1.) ..................................................3Intramammary preparations for veterinary use ........................ 714Intraruminal devices ....................................................................... 715Intrauterine capsules ...................................................................... 715Intrauterine foams ........................................................................... 715Intrauterine preparations for veterinary use ............................. 715Intrauterine solutions, suspensions............................................. 715Intrauterine sticks............................................................................ 715Intrauterine tablets.......................................................................... 715Intrinsic dissolution (2.9.29.) ........................................................ 294In vivo assay of poliomyelitis vaccine (inactivated) (2.7.20.) .. 225Iobenguane (123I) injection............................................................. 979Iobenguane (131I) injection for diagnostic use ........................... 980Iobenguane (131I) injection for therapeutic use ......................... 981Iobenguane sulfate for radiopharmaceutical preparations .... 982Iodinated (125I) human albumin injection ................................... 976Iodinated povidone........................................................................2778Iodine................................................................................................2261Iodine value (2.5.4.) ......................................................................... 137Iodixanol ..........................................................................................2261Iodomethylnorcholesterol (131I) injection ................................... 982Iohexol..............................................................................................2264Ionic concentration, potentiometric determination of usingion-selective electrodes (2.2.36.)................................................... 57

Ions and functional groups, identification reactions of(2.3.1.)............................................................................................... 107

Ion-selective electrodes, potentiometric determination of ionicconcentration (2.2.36.) ................................................................... 57

Iopamidol .........................................................................................2266Iopanoic acid...................................................................................2268Iopromide.........................................................................................2269Iotalamic acid..................................................................................2272Iotrolan.............................................................................................2273Ioxaglic acid ....................................................................................2275Ipecacuanha liquid extract, standardised ................................. 1153Ipecacuanha, prepared.................................................................. 1154Ipecacuanha root ........................................................................... 1155Ipecacuanha tincture, standardised........................................... 1156Ipratropium bromide.....................................................................2277Irbesartan ........................................................................................2278Iron (2.4.9.) .........................................................................................117Iron for homoeopathic preparations .........................................1294Irrigation, preparations for ............................................................ 731Isoconazole......................................................................................2279Isoconazole nitrate ........................................................................2281Isoelectric focusing (2.2.54.)............................................................ 83Isoelectric focusing (2.2.54.) (5.8.)............................................... 621Isoflurane.........................................................................................2282Isoleucine.........................................................................................2283Isomalt..............................................................................................2284Isoniazid...........................................................................................2285Isophane insulin injection............................................................2244Isoprenaline hydrochloride..........................................................2286Isoprenaline sulfate .......................................................................2287Isopropyl alcohol............................................................................2287Isopropyl myristate........................................................................2288Isopropyl palmitate........................................................................2289Isosorbide dinitrate, diluted .......................................................2289Isosorbide mononitrate, diluted ................................................2291Isotretinoin ......................................................................................2293Isoxsuprine hydrochloride ...........................................................2294Ispaghula husk ............................................................................... 1156



Ispaghula seed ................................................................................ 1157Isradipine .........................................................................................2296Itraconazole ....................................................................................2297Ivermectin........................................................................................2299Ivy leaf .............................................................................................. 1157

JJavanese turmeric ..........................................................................1257Java tea ............................................................................................. 1158Josamycin.........................................................................................2305Josamycin propionate....................................................................2307Juniper.............................................................................................. 1160Juniper oil ........................................................................................ 1160

KKanamycin acid sulfate ................................................................. 2313Kanamycin monosulfate ............................................................... 2313Kaolin, heavy................................................................................... 2314Kelp ................................................................................................... 1161Ketamine hydrochloride ............................................................... 2315Ketobemidone hydrochloride...................................................... 2316Ketoconazole .................................................................................. 2317Ketoprofen....................................................................................... 2318Ketorolac trometamol ...................................................................2320Ketotifen hydrogen fumarate ......................................................2321Knotgrass......................................................................................... 1162Krypton (81mKr) inhalation gas...................................................... 983

LLabetalol hydrochloride ...............................................................2327Lactic acid........................................................................................2328Lactic acid, (S)- ...............................................................................2328Lactitol monohydrate....................................................................2329Lactobionic acid .............................................................................2331Lactose, anhydrous........................................................................2331Lactose monohydrate....................................................................2333Lactulose..........................................................................................2334Lactulose, liquid .............................................................................2336Lamivudine......................................................................................2337Lamotrigine.....................................................................................2339Lansoprazole...................................................................................2341Laser light diffraction, particle size analysis by (2.9.31.) ....... 295Laurilsulfate, sodium ....................................................................2933Lauromacrogol 400 .......................................................................2342Lauroyl macrogolglycerides ........................................................2344Lavender flower.............................................................................. 1163Lavender oil..................................................................................... 1164Lavender oil, spike.........................................................................1240Lead in sugars (2.4.10.) ...................................................................117Leflunomide ....................................................................................2345Lemon oil ......................................................................................... 1165Lemon verbena leaf ....................................................................... 1166Leptospirosis vaccine (inactivated), bovine................................ 862Leptospirosis vaccine (inactivated), canine ................................ 874Letrozole ..........................................................................................2347Leucine.............................................................................................2348Leuprorelin......................................................................................2348Levamisole for veterinary use .....................................................2350Levamisole hydrochloride ............................................................2351Levetiracetam .................................................................................2352Levocabastine hydrochloride ......................................................2354Levocarnitine ..................................................................................2355Levodopa..........................................................................................2356Levodropropizine ...........................................................................2358Levofolinate pentahydrate, calcium...........................................1563Levomenthol ...................................................................................2359Levomepromazine hydrochloride...............................................2360Levomepromazine maleate ..........................................................2361Levomethadone hydrochloride ...................................................2362Levonorgestrel ................................................................................2363Levothyroxine sodium ..................................................................2364Levulinate dihydrate, calcium.....................................................1565

Lidocaine .........................................................................................2365Lidocaine hydrochloride...............................................................2366Light liquid paraffin ......................................................................2669Light magnesium carbonate........................................................2409Light magnesium oxide ................................................................ 2416Lime flower ..................................................................................... 1168Limit tests (2.4.)................................................................................ 113Limit tests, standard solutions for (4.1.2.).................................. 485Lincomycin hydrochloride ...........................................................2367Linen thread, sterile, in distributor for veterinary use .........1038Linoleoyl macrogolglycerides......................................................2368Linseed ............................................................................................. 1168Linseed oil, virgin ..........................................................................2369Liothyronine sodium.....................................................................2370Lipophilic solid dosage forms, dissolution test for (2.9.42.)... 319Liquid chromatography (2.2.29.) .................................................... 45Liquid extracts .................................................................................. 675Liquid glucose ................................................................................ 2103Liquid glucose, spray-dried.......................................................... 2103Liquid lactulose ..............................................................................2336Liquid maltitol ................................................................................2427Liquid paraffin ................................................................................2669Liquid preparations for cutaneous application ......................... 717Liquid preparations for cutaneous application, veterinary .... 740Liquid preparations for inhalation ............................................... 728Liquid preparations for oral use................................................... 718Liquids, clarity and degree of opalescence of (2.2.1.) .................21Liquid sorbitol (crystallising) ......................................................2965Liquid sorbitol (non-crystallising) ..............................................2965Liquid sorbitol, partially dehydrated .........................................2966Liquorice dry extract for flavouring purposes ........................ 1169Liquorice ethanolic liquid extract, standardised .................... 1170Liquorice root ................................................................................. 1171Lisinopril dihydrate .......................................................................2371Lithium carbonate .........................................................................2372Lithium citrate................................................................................2373L-Methionine ([11C]methyl) injection............................................ 985Lobeline hydrochloride.................................................................2373Lomustine........................................................................................2375Loosestrife ....................................................................................... 1172Loperamide hydrochloride...........................................................2376Loperamide oxide monohydrate.................................................2378Loratadine .......................................................................................2379Lorazepam.......................................................................................2381Losartan potassium.......................................................................2382Loss on drying (2.2.32.).....................................................................51Loss on drying of extracts (2.8.17.) .............................................. 244Lovage root...................................................................................... 1172Lovastatin ........................................................................................2384Low-molecular-mass heparins ..................................................... 2151Lozenges and pastilles .................................................................... 723Lozenges, compressed .................................................................... 723Lubricant, silicone oil (3.1.8.)........................................................ 347Lufenuron (anhydrous) for veterinary use ...............................2385Lymecycline.....................................................................................2387Lynestrenol......................................................................................2389Lyophilisates, oral ............................................................................ 736Lysine acetate .................................................................................2390Lysine hydrochloride.....................................................................2391

MMacrogol 15 hydroxystearate ......................................................2399Macrogol 20 glycerol monostearate ..........................................2397Macrogol 40 sorbitol heptaoleate ..............................................2404Macrogol 6 glycerol caprylocaprate...........................................2395Macrogol cetostearyl ether ..........................................................2395Macrogolglycerol cocoates...........................................................2396Macrogolglycerol hydroxystearate .............................................2397Macrogolglycerol ricinoleate .......................................................2398Macrogol lauryl ether ...................................................................2400Macrogol oleate ..............................................................................2400Macrogol oleyl ether .....................................................................2401



Macrogol poly(vinyl alcohol) grafted copolymer ....................2401Macrogols.........................................................................................2402Macrogol stearate...........................................................................2405Macrogol stearyl ether..................................................................2405Magaldrate.......................................................................................2406Magnesium (2.4.6.) ...........................................................................114Magnesium acetate tetrahydrate ................................................2407Magnesium aluminium silicate ...................................................1358Magnesium and alkaline-earth metals (2.4.7.) ............................114Magnesium aspartate dihydrate .................................................2408Magnesium carbonate, heavy ......................................................2409Magnesium carbonate, light ........................................................2409Magnesium chloride 4.5-hydrate ................................................ 2410Magnesium chloride hexahydrate .............................................. 2411Magnesium citrate, anhydrous.................................................... 2411Magnesium citrate dodecahydrate .............................................2412Magnesium citrate nonahydrate .................................................2412Magnesium gluconate................................................................... 2413Magnesium glycerophosphate..................................................... 2414Magnesium hydroxide ................................................................... 2414Magnesium lactate dihydrate ...................................................... 2415Magnesium oxide, heavy............................................................... 2415Magnesium oxide, light................................................................. 2416Magnesium peroxide ..................................................................... 2417Magnesium pidolate ...................................................................... 2417Magnesium stearate....................................................................... 2418Magnesium sulfate heptahydrate ...............................................2421Magnesium trisilicate ....................................................................2421Maize oil, refined............................................................................2422Maize starch ....................................................................................2422Malathion.........................................................................................2423Maleic acid .......................................................................................2424Malic acid .........................................................................................2424Mallow flower.................................................................................. 1173Mallow leaf....................................................................................... 1174Maltitol .............................................................................................2425Maltitol, liquid.................................................................................2427Maltodextrin....................................................................................2428Mandarin oil .................................................................................... 1175Manganese gluconate ...................................................................2428Manganese glycerophosphate, hydrated...................................2429Manganese sulfate monohydrate................................................2430Mannheimia vaccine (inactivated) for cattle ...............................911Mannheimia vaccine (inactivated) for sheep.............................. 913Mannitol ...........................................................................................2430Maprotiline hydrochloride ...........................................................2432Marbofloxacin for veterinary use ...............................................2433Marek’s disease vaccine (live).........................................................914Marshmallow leaf ........................................................................... 1176Marshmallow root .......................................................................... 1177Mass spectrometry (2.2.43.)............................................................. 67Mass spectrometry, inductively coupled plasma- (2.2.58.)........ 96Mass uniformity of delivered doses from multidose containers(2.9.27.) ............................................................................................ 294

Mass uniformity of single-dose preparations (2.9.5.) ............... 265Mastic................................................................................................ 1177Materials based on non-plasticised poly(vinyl chloride) forcontainers for dry dosage forms for oral administration(3.1.11.)............................................................................................. 350

Materials based on non-plasticised poly(vinyl chloride) forcontainers for non-injectable, aqueous solutions (3.1.10.)... 349

Materials based on plasticised poly(vinyl chloride) for containersfor aqueous solutions for intravenous infusion (3.1.14.) ...... 355

Materials based on plasticised poly(vinyl chloride) for containersfor human blood and blood components (3.1.1.1.) ................ 329

Materials based on plasticised poly(vinyl chloride) for tubingused in sets for the transfusion of blood and blood components(3.1.1.2.) ........................................................................................... 332

Materials for containers for human blood and blood components(3.1.1.)............................................................................................... 329

Materials used for the manufacture of containers (3.1.) ......... 329Matricaria flower ............................................................................ 1178Matricaria liquid extract ............................................................... 1179

Matricaria oil ................................................................................... 1180Meadowsweet .................................................................................. 1182Measles immunoglobulin, human .............................................. 2177Measles, mumps and rubella vaccine (live) ................................ 798Measles, mumps, rubella and varicella vaccine (live)............... 799Measles vaccine (live) ...................................................................... 800Measurement of consistency by penetrometry (2.9.9.) ............ 267Mebendazole ...................................................................................2434Meclozine dihydrochloride ..........................................................2435Medicated chewing gums............................................................... 709Medicated chewing gums, dissolution test for (2.9.25.) .......... 289Medicated feeding stuffs for veterinary use, premixes for ...... 727Medicated foams............................................................................... 712Medicated plasters ........................................................................... 735Medicated tampons.......................................................................... 738Medicated vaginal tampons ........................................................... 740Medicinal air.................................................................................... 1331Medicinal air, synthetic.................................................................1333Medium-chain triglycerides.......................................................... 3138Medronic acid for radiopharmaceutical preparations.............. 984Medroxyprogesterone acetate .....................................................2437Mefenamic acid ...............................................................................2438Mefloquine hydrochloride............................................................2440Megestrol acetate ...........................................................................2441Meglumine.......................................................................................2442Melilot............................................................................................... 1183Melissa leaf ...................................................................................... 1184Melissa leaf dry extract ................................................................. 1185Meloxicam........................................................................................2443Melting point - capillary method (2.2.14.)......................................31Melting point - instantaneous method (2.2.16.) .......................... 32Melting point - open capillary method (2.2.15.) .......................... 32Menadione .......................................................................................2444Meningococcal group C conjugate vaccine................................ 802Meningococcal polysaccharide vaccine....................................... 803Menthol, racemic............................................................................2445Mepivacaine hydrochloride..........................................................2446Meprobamate ..................................................................................2447Mepyramine maleate .....................................................................2448Mercaptopurine ..............................................................................2449Mercuric chloride...........................................................................2449Mercury porosimetry, porosity and pore-size distribution ofsolids by (2.9.32.) ........................................................................... 299

Meropenem trihydrate ..................................................................2450Mesalazine .......................................................................................2451Mesna................................................................................................2453Mesterolone.....................................................................................2454Mestranol .........................................................................................2455Metabisulfite, sodium....................................................................2933Metacresol .......................................................................................2456Metamizole sodium .......................................................................2457Metformin hydrochloride .............................................................2458Methacrylate copolymer, basic butylated .................................1448Methacrylic acid - ethyl acrylate copolymer (1:1) ...................2459Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion30 per cent ....................................................................................2460

Methacrylic acid - methyl methacrylate copolymer (1:1) ......2461Methacrylic acid - methyl methacrylate copolymer (1:2) ......2461Methadone hydrochloride............................................................2462Methanol ..........................................................................................2463Methanol and 2-propanol, test for (2.9.11.) ................................ 270Methaqualone .................................................................................2464Methenamine ..................................................................................2465Methionine ......................................................................................2466Methionine ([11C]methyl) injection, L-.......................................... 985Methionine, DL- ...............................................................................2466Methods in pharmacognosy (2.8.) ................................................ 239Methods of preparation of homoeopathic stocks andpotentisation.................................................................................1277

Methods of preparation of sterile products (5.1.1.) .................. 503Methotrexate ...................................................................................2467Methylatropine bromide ...............................................................2469Methylatropine nitrate ..................................................................2470



Methylcellulose...............................................................................2471Methyldopa......................................................................................2472Methylene blue ...............................................................................2490Methylene chloride ........................................................................2474Methylergometrine maleate.........................................................2475Methylhydroxyethylcellulose .......................................................2476Methyl nicotinate ...........................................................................2477Methyl parahydroxybenzoate ......................................................2477Methyl parahydroxybenzoate, sodium ......................................2934Methylpentoses in polysaccharide vaccines (2.5.21.) ............... 143Methylphenidate hydrochloride..................................................2479Methylphenobarbital .....................................................................2480Methylprednisolone.......................................................................2481Methylprednisolone acetate.........................................................2483Methylprednisolone hydrogen succinate ..................................2485Methylpyrrolidone, N- ...................................................................2486Methylrosanilinium chloride .......................................................2487Methyl salicylate.............................................................................2488Methyltestosterone ........................................................................2489Methylthioninium chloride ..........................................................2490Metixene hydrochloride................................................................2491Metoclopramide..............................................................................2492Metoclopramide hydrochloride...................................................2493Metolazone ......................................................................................2494Metoprolol succinate.....................................................................2495Metoprolol tartrate ........................................................................2497Metrifonate ......................................................................................2498Metronidazole .................................................................................2500Metronidazole benzoate ...............................................................2500Mexiletine hydrochloride..............................................................2502Mianserin hydrochloride ..............................................................2503Miconazole ......................................................................................2504Miconazole nitrate .........................................................................2506Microbial enumeration tests (microbiological examination ofnon-sterile products) (2.6.12.) ..................................................... 163

Microbial enumeration tests (microbiological examination ofnon-sterile products) (2.6.12.) (5.8.) .......................................... 622

Microbiological assay of antibiotics (2.7.2.)................................ 202Microbiological control of cellular products (2.6.27.).............. 191Microbiological examination of herbal medicinal products fororal use (2.6.31.)............................................................................. 197

Microbiological examination of non-sterile products : microbialenumeration tests (2.6.12.).......................................................... 163

Microbiological examination of non-sterile products : microbialenumeration tests (2.6.12.) (5.8.) ............................................... 622

Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) ........................................... 167

Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) (5.8.)................................. 622

Microbiological quality, alternative methods for control of(5.1.6.)............................................................................................... 508

Microbiological quality of herbal medicinal products for oral use(5.1.8.)............................................................................................... 519

Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use(5.1.4.)............................................................................................... 507

Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use (5.1.4.)(5.8.).................................................................................................. 623

Microbiology, general texts on (5.1.) ........................................... 503Microcrystalline cellulose.............................................................1634Microcrystalline cellulose and carmellose sodium.................2507Micro determination of water (2.5.32.)........................................ 146Microscopic examination of herbal drugs (2.8.23) ................... 250Microscopy, optical (2.9.37.) ...........................................................311Microscopy, optical (2.9.37.) (5.8.) ............................................... 622Midazolam .......................................................................................2508Milk thistle dry extract, refined and standardised.................. 1186Milk-thistle fruit.............................................................................. 1187Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.) ............................................................................. 539

Minocycline hydrochloride dihydrate ........................................ 2510

Minoxidil .......................................................................................... 2511Mint oil, partly dementholised .................................................... 1189Mirtazapine ..................................................................................... 2512Misoprostol...................................................................................... 2513Mitomycin ........................................................................................ 2515Mitoxantrone hydrochloride........................................................ 2517Modafinil .......................................................................................... 2518Modified-release capsules............................................................... 708Modified-release granules .............................................................. 714Modified-release tablets .................................................................. 738Mofetil mycophenolate..................................................................2536Molecular mass distribution in dextrans (2.2.39.) ...................... 60Molgramostim concentrated solution ....................................... 2519Molsidomine....................................................................................2521Molybdate dihydrate, sodium......................................................2935Mometasone furoate......................................................................2523Monoclonal antibodies for human use........................................ 682Monocyte-activation test (2.6.30.)................................................. 192Morantel hydrogen tartrate for veterinary use .......................2525Morphine hydrochloride...............................................................2526Morphine sulfate ............................................................................2527Moss, Iceland .................................................................................. 1152Mother tinctures for homoeopathic preparations ..................1286Motherwort ..................................................................................... 1190Mouthwashes .................................................................................... 722Moxidectin for veterinary use .....................................................2529Moxifloxacin hydrochloride .........................................................2531Moxonidine......................................................................................2532Mucoadhesive preparations ........................................................... 723Mullein flower................................................................................. 1191Multidose containers, uniformity of mass of delivered doses(2.9.27.) ............................................................................................ 294

Mumps, measles and rubella vaccine (live) ................................ 798Mumps, measles, rubella and varicella vaccine (live)............... 799Mumps vaccine (live) ....................................................................... 805Mupirocin.........................................................................................2533Mupirocin calcium .........................................................................2535Mycobacteria (2.6.2.) ....................................................................... 156Mycophenolate mofetil..................................................................2536Mycoplasma gallisepticum vaccine (inactivated)....................... 916Mycoplasmas (2.6.7.)........................................................................ 156myo-Inositol ....................................................................................2236Myrrh ................................................................................................ 1192Myrrh tincture ................................................................................ 1192Myxomatosis vaccine (live) for rabbits .........................................917

NNabumetone ....................................................................................2541N-Acetyltryptophan........................................................................ 1319N-Acetyltyrosine .............................................................................1320Nadolol .............................................................................................2542Nadroparin calcium .......................................................................2543Naftidrofuryl hydrogen oxalate...................................................2545Nalidixic acid...................................................................................2547Naloxone hydrochloride dihydrate.............................................2548Naltrexone hydrochloride.............................................................2549Nandrolone decanoate ..................................................................2551Naphazoline hydrochloride..........................................................2552Naphazoline nitrate .......................................................................2553Naproxen..........................................................................................2554Naproxen sodium ...........................................................................2556Narrow-leaved coneflower root ................................................... 1193Nasal drops and liquid nasal sprays............................................. 720Nasal powders................................................................................... 721Nasal preparations ........................................................................... 719Nasal preparations, semi-solid....................................................... 721Nasal sprays (liquid) and nasal drops .......................................... 719Nasal sticks........................................................................................ 721Nasal washes ..................................................................................... 721Near-infrared spectrophotometry (2.2.40.)....................................61Neohesperidin-dihydrochalcone .................................................2558Neomycin sulfate............................................................................2559



Neonatal piglet colibacillosis vaccine (inactivated) .................. 918Neonatal ruminant colibacillosis vaccine (inactivated) ........... 920Neostigmine bromide ....................................................................2560Neostigmine metilsulfate..............................................................2561Neroli oil .......................................................................................... 1194Netilmicin sulfate ...........................................................................2562Nettle leaf......................................................................................... 1196Neurovirulence test for poliomyelitis vaccine (oral) (2.6.19.).. 179Neurovirulence test of live viral vaccines (2.6.18.) ................... 179Nevirapine, anhydrous ..................................................................2563Newcastle disease vaccine (inactivated) ...................................... 921Newcastle disease vaccine (live).................................................... 923Nicergoline ......................................................................................2564Nickel in hydrogenated vegetable oils (2.4.31.)......................... 132Nickel in polyols (2.4.15.) ............................................................... 118Niclosamide, anhydrous ...............................................................2565Niclosamide monohydrate ...........................................................2566Nicotinamide ...................................................................................2567Nicotine ............................................................................................2567Nicotine resinate ............................................................................2568Nicotinic acid ..................................................................................2570Nifedipine.........................................................................................2571Niflumic acid ...................................................................................2572Nifuroxazide ....................................................................................2574Nikethamide ....................................................................................2575Nilutamide .......................................................................................2575Nimesulide.......................................................................................2577Nimodipine ......................................................................................2578Nitrazepam ......................................................................................2579Nitrendipine ....................................................................................2580Nitric acid ........................................................................................2581Nitric oxide ......................................................................................2581Nitrofural .........................................................................................2582Nitrofurantoin.................................................................................2583Nitrogen ...........................................................................................2584Nitrogen determination by sulfuric acid digestion (2.5.9.) ..... 139Nitrogen determination, primary aromatic amino (2.5.8.) ...... 139Nitrogen, low-oxygen.....................................................................2585Nitrogen monoxide and nitrogen dioxide in gases (2.5.26.)... 145Nitroprusside, sodium...................................................................2936Nitrous oxide...................................................................................2585Nitrous oxide in gases (2.5.35.)..................................................... 150Nizatidine.........................................................................................2586N-Methylpyrrolidone......................................................................2486NMR spectrometry (2.2.33.)............................................................. 52N,N-Dimethylaniline (2.4.26.) ........................................................ 128Nomegestrol acetate......................................................................2588Nonoxinol 9.....................................................................................2589Non-sterile pharmaceutical preparations and substances forpharmaceutical use, microbiological quality of (5.1.4.)......... 507

Non-sterile pharmaceutical preparations and substancesfor pharmaceutical use, microbiological quality of (5.1.4.)(5.8.).................................................................................................. 623

Non-sterile products, microbiological examination of (microbialenumeration tests) (2.6.12.)......................................................... 163

Non-sterile products, microbiological examination of (microbialenumeration tests) (2.6.12.) (5.8.).............................................. 622

Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.) .......................................... 167

Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.) (5.8.) ............................... 622

Noradrenaline hydrochloride ......................................................2589Noradrenaline tartrate ..................................................................2591Norepinephrine hydrochloride....................................................2589Norepinephrine tartrate ...............................................................2591Norethisterone................................................................................2592Norethisterone acetate .................................................................2594Norfloxacin......................................................................................2595Norgestimate ...................................................................................2596Norgestrel ........................................................................................2597Normal immunoglobulin for intravenous administration,human ............................................................................................ 2179

Normal immunoglobulin, human............................................... 2177

Nortriptyline hydrochloride.........................................................2598Noscapine ........................................................................................2599Noscapine hydrochloride..............................................................2600Notoginseng root ........................................................................... 1197Nuclear magnetic resonance spectrometry (2.2.33.).................. 52Nucleated cell count and viability (2.7.29.) ................................ 233Nucleic acid amplification techniques (2.6.21.) ......................... 181Nucleic acids in polysaccharide vaccines (2.5.17.) .................... 142Numeration of CD34/CD45+ cells in haematopoietic products(2.7.23.) ............................................................................................ 228

Nutmeg oil ....................................................................................... 1199Nystatin ............................................................................................2602

OO-Acetyl in polysaccharide vaccines (2.5.19.) ............................ 142Oak bark .......................................................................................... 1199Octoxinol 10 ....................................................................................2607Octyldodecanol ...............................................................................2608Octyl gallate ....................................................................................2607Odour (2.3.4.).................................................................................... 110Odour and taste of essential oils (2.8.8.) .................................... 240Ofloxacin..........................................................................................2609Oils, essential .................................................................................... 673Oils, fatty, identification by thin-layer chromatography(2.3.2.) .............................................................................................. 110

Oils, fatty, vegetable ........................................................................ 703Oils rich in omega-3 acids, composition of fatty acids in(2.4.29.) ............................................................................................ 130

Oils rich in omega-3 acids, total cholesterol in (2.4.32.) ......... 133Ointments .......................................................................................... 735Oleic acid ......................................................................................... 2610Oleoresins .......................................................................................... 676Oleoyl macrogolglycerides ........................................................... 2610Oleyl alcohol ................................................................................... 2611Olive leaf ..........................................................................................1200Olive leaf dry extract ..................................................................... 1201Olive oil, refined .............................................................................2612Olive oil, virgin ............................................................................... 2613Olsalazine sodium.......................................................................... 2613Omega-3-acid ethyl esters 60....................................................... 2616Omega-3-acid ethyl esters 90....................................................... 2617Omega-3 acids, composition of fatty acids in oils rich in(2.4.29.) ............................................................................................ 130

Omega-3 acids, fish oil rich in ..................................................... 2019Omega-3 acids, total cholesterol in oils rich in (2.4.32.) ......... 133Omega-3-acid triglycerides ........................................................... 2619Omeprazole .....................................................................................2621Omeprazole magnesium...............................................................2623Omeprazole sodium.......................................................................2624Ondansetron hydrochloride dihydrate ......................................2625Opalescence of liquids, clarity and degree of (2.2.1.)..................21Ophthalmic inserts .......................................................................... 712Opium dry extract, standardised ................................................1202Opium, prepared.............................................................................1203Opium, raw ......................................................................................1204Opium tincture, standardised......................................................1205Optical microscopy (2.9.37.) ...........................................................311Optical microscopy (2.9.37.) (5.8.)................................................ 622Optical rotation (2.2.7.)..................................................................... 26Oral drops .......................................................................................... 719Oral lyophilisates.............................................................................. 736Oral powders..................................................................................... 727Oral solutions, emulsions and suspensions ............................... 718Oral use, liquid preparations for................................................... 718Orbifloxacin for veterinary use ...................................................2627Orciprenaline sulfate .....................................................................2628Oregano............................................................................................1206Organ preservation, solutions for...............................................2952Oriental cashew for homoeopathic preparations....................1295Orodispersible tablets ..................................................................... 737Oromucosal capsules ...................................................................... 723



Oromucosal drops, oromucosal sprays and sublingualsprays................................................................................................ 722

Oromucosal preparations............................................................... 721Oromucosal preparations, semi-solid........................................... 722Oromucosal solutions and oromucosal suspensions ............... 722Oromucosal sprays, oromucosal drops and sublingualsprays................................................................................................ 721

Oromucosal suspensions and oromucosal solutions ............... 721Orphenadrine citrate.....................................................................2630Orphenadrine hydrochloride.......................................................2631Osmolality (2.2.35.)............................................................................ 57Ouabain............................................................................................2632Oxacillin sodium monohydrate ...................................................2633Oxaliplatin .......................................................................................2635Oxazepam ........................................................................................2638Oxeladin hydrogen citrate............................................................2639Oxfendazole for veterinary use...................................................2640Oxidising substances (2.5.30.)....................................................... 146Oxitropium bromide ......................................................................2641Oxolinic acid....................................................................................2642Oxprenolol hydrochloride ............................................................2643Oxybuprocaine hydrochloride.....................................................2644Oxybutynin hydrochloride ...........................................................2645Oxycodone hydrochloride ............................................................2646Oxygen..............................................................................................2648Oxygen (15O) ...................................................................................... 986Oxygen-flask method (2.5.10.)....................................................... 139Oxygen in gases (2.5.27.)................................................................ 145Oxymetazoline hydrochloride .....................................................2648Oxytetracycline dihydrate ............................................................2649Oxytetracycline hydrochloride ....................................................2651Oxytocin ...........................................................................................2653Oxytocin concentrated solution..................................................2654

PPaclitaxel..........................................................................................2657Pale coneflower root .....................................................................1208Palmitic acid....................................................................................2660Pamidronate disodium pentahydrate ........................................2660Pancreas powder ............................................................................2661Pancuronium bromide ..................................................................2663Pansy, wild (flowering aerial parts) ...........................................1266Pantoprazole sodium sesquihydrate..........................................2664Pantothenate, calcium ..................................................................1566Papaverine hydrochloride ............................................................2666Paper chromatography (2.2.26.) ......................................................41Paracetamol ....................................................................................2667Paraffin, hard ..................................................................................2668Paraffin, light liquid ......................................................................2669Paraffin, liquid ................................................................................2669Paraffin, white soft ........................................................................2670Paraffin, yellow soft.......................................................................2671Parahydroxybenzoate, butyl ........................................................1530Parahydroxybenzoate, ethyl ........................................................1973Parahydroxybenzoate, methyl.....................................................2477Parahydroxybenzoate, propyl...................................................... 2813Parahydroxybenzoate sodium, ethyl.......................................... 1974Parahydroxybenzoate, sodium methyl ......................................2934Parahydroxybenzoate, sodium propyl .......................................2942Parainfluenza virus vaccine (live), bovine.................................. 864Parainfluenza virus vaccine (live), canine .................................. 875Paraldehyde.....................................................................................2671Paramyxovirus 1 (Newcastle disease) vaccine (inactivated),avian ................................................................................................. 921

Parenteral preparations.................................................................. 723Parenteral preparations, test for extractable volume of(2.9.17.)............................................................................................. 273

Parenteral preparations, test for extractable volume of (2.9.17.)(5.8.).................................................................................................. 622

Parnaparin sodium ........................................................................2672Paroxetine hydrochloride, anhydrous .......................................2672Paroxetine hydrochloride hemihydrate.....................................2674

Particles, fine, aerodynamic assessment of in preparations forinhalation (2.9.18.) ........................................................................ 274

Particle size analysis by laser light diffraction (2.9.31.) .......... 295Particle-size distribution estimation by analytical sieving(2.9.38.) ............................................................................................ 313

Particle-size distribution estimation by analytical sieving(2.9.38.) (5.8.) ................................................................................. 623

Particulate contamination : sub-visible particles (2.9.19.)....... 285Particulate contamination : visible particles (2.9.20.) .............. 287Parvovirosis vaccine (inactivated), canine .................................. 876Parvovirosis vaccine (inactivated), porcine ................................ 930Parvovirosis vaccine (live), canine................................................ 877Passion flower ................................................................................1209Passion flower dry extract ........................................................... 1210Pastes.................................................................................................. 735Pasteurella vaccine (inactivated) for sheep ................................ 925Pastilles and lozenges..................................................................... 723Patches, cutaneous.......................................................................... 734Patches, transdermal....................................................................... 726Patches, transdermal, dissolution test for (2.9.4.) .................... 263Pea starch ........................................................................................2676Pefloxacin mesilate dihydrate .....................................................2677Pelargonium root ........................................................................... 1211Penbutolol sulfate..........................................................................2678Penetrometry, measurement of consistency by (2.9.9.)........... 267Penicillamine...................................................................................2679Pentaerythrityl tetranitrate, diluted ..........................................2681Pentamidine diisetionate..............................................................2683Pentazocine.....................................................................................2684Pentazocine hydrochloride ..........................................................2684Pentazocine lactate .......................................................................2685Pentetate sodium calcium for radiopharmaceuticalpreparations .................................................................................... 987

Pentobarbital ..................................................................................2685Pentobarbital sodium....................................................................2686Pentoxifylline ..................................................................................2687Pentoxyverine hydrogen citrate ..................................................2689Peppermint leaf .............................................................................. 1212Peppermint leaf dry extract ......................................................... 1213Peppermint oil ................................................................................ 1214Pepsin powder ................................................................................2690Peptide mapping (2.2.55.) ................................................................ 85Peptide mapping (2.2.55.) (5.8.) ................................................... 621Peptides, synthetic, acetic acid in (2.5.34.)................................. 150Perborate, hydrated sodium ........................................................2937Pergolide mesilate..........................................................................2691Perindopril tert-butylamine..........................................................2692Peritoneal dialysis, solutions for.................................................2695Peroxide value (2.5.5.)..................................................................... 138Perphenazine ..................................................................................2697Pertussis (acellular, component), diphtheria and tetanus vaccine(adsorbed)........................................................................................ 754

Pertussis (acellular, component), diphtheria, tetanus andhaemophilus type b conjugate vaccine (adsorbed) ................ 758

Pertussis (acellular, component), diphtheria, tetanus andhepatitis B (rDNA) vaccine (adsorbed) ..................................... 760

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed) ........................ 762

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ........................................................................ 763

Pertussis (acellular, component), diphtheria, tetanus, hepatitis B(rDNA), poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed)...................................................... 765

Pertussis (acellular, component), diphtheria, tetanus,poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed)......................................................................... 768

Pertussis, diphtheria, tetanus and poliomyelitis (inactivated)vaccine (adsorbed)......................................................................... 771

Pertussis, diphtheria, tetanus, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ................ 772

Pertussis vaccine (acellular), assay of (2.7.16.).......................... 223Pertussis vaccine (acellular, component, adsorbed) ................ 806



Pertussis vaccine (acellular, co-purified, adsorbed) ................. 808Pertussis vaccine, assay of (2.7.7.) ................................................ 213Pertussis vaccine (whole cell, adsorbed)..................................... 810Peru balsam..................................................................................... 1215Pessaries............................................................................................. 739Pessaries and suppositories, disintegration of (2.9.2.) ............ 255Pesticide residues (2.8.13.)............................................................. 242Pethidine hydrochloride...............................................................2698Pharmaceutical technical procedures (2.9.)............................... 253Pharmacognosy, methods in (2.8.)............................................... 239Pharmacopoeial harmonisation (5.8.) ......................................... 621Phenazone.......................................................................................2699Pheniramine maleate ....................................................................2700Phenobarbital .................................................................................2702Phenobarbital sodium...................................................................2702Phenol ..............................................................................................2703Phenol in immunosera and vaccines (2.5.15.) ............................141Phenolphthalein.............................................................................2704Phenolsulfonphthalein .................................................................2704Phenothiazines, identification by thin-layer chromatography(2.3.3.) .............................................................................................. 110

Phenoxyethanol..............................................................................2705Phenoxymethylpenicillin ..............................................................2706Phenoxymethylpenicillin potassium..........................................2708Phentolamine mesilate .................................................................2709Phenylalanine ................................................................................. 2711Phenylbutazone ............................................................................. 2711Phenylbutyrate, sodium................................................................2938Phenylephrine.................................................................................2713Phenylephrine hydrochloride...................................................... 2714Phenylmercuric acetate ................................................................2715Phenylmercuric borate .................................................................2716Phenylmercuric nitrate .................................................................2716Phenylpropanolamine hydrochloride ........................................ 2717Phenytoin.........................................................................................2718Phenytoin sodium..........................................................................2719Phloroglucinol, anhydrous ..........................................................2720Phloroglucinol dihydrate .............................................................2722Pholcodine.......................................................................................2724Phosphates (2.4.11.) .........................................................................117Phosphoric acid, concentrated ...................................................2725Phosphoric acid, dilute .................................................................2725Phosphorus in polysaccharide vaccines (2.5.18.) ..................... 142pH, potentiometric determination of (2.2.3.) ............................... 24Phthalylsulfathiazole ....................................................................2726Physical and physicochemical methods (2.2.) ..............................21Physostigmine salicylate...............................................................2726Physostigmine sulfate ...................................................................2727Phytomenadione ............................................................................2728Phytosterol ......................................................................................2729Picosulfate, sodium .......................................................................2939Picotamide monohydrate .............................................................2730Pilocarpine hydrochloride............................................................2731Pilocarpine nitrate .........................................................................2732Pimobendan ....................................................................................2734Pimozide ..........................................................................................2734Pindolol ............................................................................................2736Pine (dwarf) oil ............................................................................... 1116Pine sylvestris oil ........................................................................... 1216Pinus pinaster type turpentine oil .............................................1258Pipemidic acid trihydrate .............................................................2737Piperacillin ......................................................................................2738Piperacillin sodium........................................................................2739Piperazine adipate ......................................................................... 2741Piperazine citrate...........................................................................2742Piperazine hydrate.........................................................................2743Piracetam.........................................................................................2743Pirenzepine dihydrochloride monohydrate .............................2744Piretanide ........................................................................................2746Piroxicam .........................................................................................2747Pivampicillin....................................................................................2748Pivmecillinam hydrochloride.......................................................2750Plasma for fractionation, human................................................ 2181

Plasma (pooled and treated for virus inactivation), human.. 2182Plasmid vectors for human use, bacterial cells used for themanufacture of ............................................................................... 649

Plasmin inhibitor, assay of human (2.7.25.) ............................... 230Plasters, medicated.......................................................................... 734Plastic additives (3.1.13.)................................................................ 352Plastic containers and closures for pharmaceutical use(3.2.2.) .............................................................................................. 368

Plastic containers for aqueous solutions for infusion(3.2.2.1.) ........................................................................................... 368

Plastic containers for human blood and blood components,sterile (3.2.3.) .................................................................................. 369

Plastic syringes, single-use, sterile (3.2.8.) ................................. 373Pneumococcal polysaccharide conjugate vaccine(adsorbed)........................................................................................ 812

Pneumococcal polysaccharide vaccine ....................................... 813Pneumonia vaccine (inactivated), porcine enzootic ................. 927Poliomyelitis (inactivated), diphtheria and tetanus vaccine(adsorbed, reduced antigen(s) content) .................................... 756

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) .............................. 762

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed, reduced antigen(s)content)............................................................................................ 763

Poliomyelitis (inactivated), diphtheria, tetanus and pertussisvaccine (adsorbed)......................................................................... 771

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed)......................................................................... 768

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and haemophilustype b conjugate vaccine (adsorbed) ......................................... 765

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis andhaemophilus type b conjugate vaccine (adsorbed) ................ 772

Poliomyelitis vaccine (inactivated) ............................................... 815Poliomyelitis vaccine (inactivated), in vivo assay of (2.7.20.) .. 225Poliomyelitis vaccine (oral) ............................................................ 818Poliomyelitis vaccine (oral), test for neurovirulence (2.6.19.).. 179Poloxamers ......................................................................................2751Polyacrylate dispersion 30 per cent...........................................2752Polyamide 6/6 suture, sterile, in distributor for veterinary use.........................................................................................................1038

Polyamide 6 suture, sterile, in distributor for veterinary use.........................................................................................................1038

Polyethyleneglycols .......................................................................2402Polyethylene terephthalate for containers for preparations notfor parenteral use (3.1.15.) .......................................................... 357

Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use ..............................................................................1039

Poly(ethylene - vinyl acetate) for containers and tubing for totalparenteral nutrition preparations (3.1.7.)................................. 345

Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.5.) ......... 338

Polyethylene without additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.4.) ......... 337

Polymorphism (5.9.) ........................................................................ 627Polymyxin B sulfate.......................................................................2753Polyolefines (3.1.3.) ......................................................................... 334Polyoxyl castor oil..........................................................................2398Polyoxyl hydrogenated castor oil ...............................................2397Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.)................ 342

Polysaccharide vaccines, hexosamines in (2.5.20.)................... 142Polysaccharide vaccines, methylpentoses in (2.5.21.).............. 143Polysaccharide vaccines, nucleic acids in (2.5.17.) ................... 142Polysaccharide vaccines, O-acetyl in (2.5.19.)............................ 142Polysaccharide vaccines, phosphorus in (2.5.18.)..................... 142Polysaccharide vaccines, protein in (2.5.16.) ..............................141Polysaccharide vaccines, ribose in (2.5.31.) ............................... 146Polysaccharide vaccines, sialic acid in (2.5.23.) ........................ 143Polysaccharide vaccines, uronic acids in (2.5.22.) .................... 143Polysorbate 20 ................................................................................2754Polysorbate 40 ................................................................................2755



Polysorbate 60 ................................................................................2756Polysorbate 80 ................................................................................2756Polystyrene sulfonate, sodium ....................................................2940Poly(vinyl acetate)..........................................................................2758Poly(vinyl acetate) dispersion 30 per cent ...............................2759Poly(vinyl alcohol) .........................................................................2760Poly(vinyl alcohol) macrogol grafted copolymer ....................2401Poly(vinyl chloride) (non-plasticised) for containers for drydosage forms for oral administration, materials based on(3.1.11.)............................................................................................. 350

Poly(vinyl chloride), non-plasticised, materials based on forcontainers for non-injectable aqueous solutions (3.1.10.).... 349

Poly(vinyl chloride), plasticised, empty sterile containers of forhuman blood and blood components (3.2.4.).......................... 370

Poly(vinyl chloride), plasticised, materials based on forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ............................................................................................ 355

Poly(vinyl chloride), plasticised, materials based on forcontainers for human blood and blood components(3.1.1.1.) ........................................................................................... 329

Poly(vinyl chloride), plasticised, materials based on for tubingused in sets for the transfusion of blood and blood components(3.1.1.2.) ........................................................................................... 332

Poly(vinyl chloride), plasticised, sterile containers of for humanblood containing anticoagulant solution (3.2.5.) ................... 371

Poppy petals, red............................................................................1222Porcine actinobacillosis vaccine (inactivated) ........................... 926Porcine enzootic pneumonia vaccine (inactivated) .................. 927Porcine influenza vaccine (inactivated) ...................................... 929Porcine insulin................................................................................2247Porcine parvovirosis vaccine (inactivated) ................................. 930Porcine progressive atrophic rhinitis vaccine (inactivated) .... 931Pore-size distribution of solids by mercury porosimetry, porosityand (2.9.32.) .................................................................................... 299

Porosimetry, mercury, porosity and pore-size distribution ofsolids by (2.9.32.) ........................................................................... 299

Porosity and pore-size distribution of solids by mercuryporosimetry (2.9.32.)..................................................................... 299

Porosity of sintered-glass filters (2.1.2.) ........................................ 15Porous solids including powders, wettability of (2.9.45.) ....... 321Potassium (2.4.12.) ...........................................................................117Potassium acetate .......................................................................... 2761Potassium bromide ........................................................................ 2761Potassium carbonate.....................................................................2762Potassium chloride ........................................................................2763Potassium citrate ...........................................................................2763Potassium clavulanate ..................................................................2764Potassium clavulanate, diluted ...................................................2766Potassium dihydrogen phosphate ..............................................2768Potassium hydrogen aspartate hemihydrate ...........................2768Potassium hydrogen carbonate ..................................................2769Potassium hydrogen tartrate.......................................................2769Potassium hydroxide .....................................................................2770Potassium iodide............................................................................2771Potassium metabisulfite ...............................................................2771Potassium nitrate ...........................................................................2772Potassium perchlorate ..................................................................2773Potassium permanganate.............................................................2773Potassium sodium tartrate tetrahydrate...................................2774Potassium sorbate..........................................................................2774Potassium sulfate ...........................................................................2775Potato starch...................................................................................2775Potentiometric determination of ionic concentration usingion-selective electrodes (2.2.36.)................................................... 57

Potentiometric determination of pH (2.2.3.)................................ 24Potentiometric titration (2.2.20.).................................................... 34Potentisation, methods of preparation of homoeopathic stocksand ..................................................................................................1277

Poultices............................................................................................. 735Pour-on preparations ...................................................................... 740Povidone ..........................................................................................2776Povidone, iodinated .......................................................................2778Powdered cellulose ........................................................................1638

Powder fineness (2.9.35.) ............................................................... 308Powder flow (2.9.36.) ...................................................................... 308Powder flow (2.9.36.) (5.8.) ........................................................... 622Powders and granules for oral solutions and suspensions .... 718Powders and granules for syrups ................................................. 719Powders and tablets for rectal solutions and suspensions..... 733Powders, bulk density and tapped density of (2.9.34.) ............ 305Powders, ear...................................................................................... 710Powders, effervescent...................................................................... 727Powders for cutaneous application.............................................. 726Powders for eye drops and powders for eye lotions................. 711Powders for inhalation.................................................................... 730Powders for injections or infusions ............................................. 725Powders for oral drops.................................................................... 719Powders, nasal .................................................................................. 721Powders, oral .................................................................................... 727Powders, wettability of porous solids including (2.9.45.) ....... 321Pramipexole dihydrochloride monohydrate ............................2779Pravastatin sodium........................................................................2780Prazepam .........................................................................................2782Praziquantel ....................................................................................2783Prazosin hydrochloride ................................................................2784Prednicarbate..................................................................................2785Prednisolone ...................................................................................2786Prednisolone acetate.....................................................................2787Prednisolone pivalate....................................................................2789Prednisolone sodium phosphate ................................................2790Prednisone.......................................................................................2791Pregelatinised starch.....................................................................2983Prekallikrein activator (2.6.15.) .................................................... 175Premixes for medicated feeding stuffs for veterinary use....... 727Preparations for inhalation............................................................ 728Preparations for inhalation: aerodynamic assessment of fineparticles (2.9.18.) ........................................................................... 274

Preparations for irrigation............................................................. 731Pressurised pharmaceutical preparations .................................. 732Prilocaine.........................................................................................2792Prilocaine hydrochloride..............................................................2794Primaquine diphosphate ..............................................................2795Primary aromatic amino-nitrogen, determination of (2.5.8.) .. 139Primary standards for volumetric solutions (4.2.1.)................. 494Primidone ........................................................................................2796Primula root .................................................................................... 1217Probenecid.......................................................................................2797Procainamide hydrochloride .......................................................2798Procaine benzylpenicillin ............................................................. 1474Procaine hydrochloride ................................................................2798Prochlorperazine maleate ............................................................2799Products of fermentation ............................................................... 685Products of recombinant DNA technology ................................ 692Products with risk of transmitting agents of animal spongiformencephalopathies ........................................................................... 686

Progenitor cells, human haematopoietic, colony-forming cellassay for (2.7.28.) ........................................................................... 232

Progesterone ...................................................................................2800Progressive atrophic rhinitis vaccine (inactivated), porcine... 931Proguanil hydrochloride ..............................................................2801Proline ..............................................................................................2802Promazine hydrochloride.............................................................2803Promethazine hydrochloride.......................................................2804Propacetamol hydrochloride .......................................................2805Propafenone hydrochloride .........................................................2806Propanol...........................................................................................2808Propanol and methanol, 2-, test for (2.9.11.) ............................. 270Propantheline bromide.................................................................2809Propofol............................................................................................ 2810Propranolol hydrochloride........................................................... 2811Propylene glycol............................................................................. 2814Propylene glycol dicaprylocaprate............................................. 2815Propylene glycol dilaurate ........................................................... 2815Propylene glycol monolaurate .................................................... 2816Propylene glycol monopalmitostearate..................................... 2817Propylene glycol monostearate................................................... 2817



Propyl gallate ..................................................................................2812Propyl parahydroxybenzoate....................................................... 2813Propyl parahydroxybenzoate, sodium.......................................2942Propylthiouracil ............................................................................. 2818Propyphenazone ............................................................................ 2819Protamine hydrochloride .............................................................2820Protamine sulfate...........................................................................2821Protein C, human, assay of (2.7.30.) ............................................ 234Protein in polysaccharide vaccines (2.5.16.) ...............................141Protein S, human, assay of (2.7.31.)............................................. 235Protein, total (2.5.33.) ..................................................................... 147Prothrombin complex, human .................................................... 2185Protirelin ..........................................................................................2822Proxyphylline ..................................................................................2823Pseudoephedrine hydrochloride ................................................2824Psyllium seed .................................................................................. 1217Purified water .................................................................................3224Purified water, highly ...................................................................3222Purple coneflower herb................................................................ 1218Purple coneflower root................................................................. 1219Pycnometric density of solids, gas (2.9.23.) ............................... 288Pygeum africanum bark ...............................................................1221Pyrantel embonate.........................................................................2825Pyrazinamide ..................................................................................2826Pyridostigmine bromide ...............................................................2827Pyridoxine hydrochloride.............................................................2827Pyrimethamine ...............................................................................2829Pyrogens (2.6.8.)............................................................................... 161Pyrrolidone......................................................................................2829

QQuality of non-sterile pharmaceutical preparations andsubstances for pharmaceutical use, microbiological(5.1.4.)............................................................................................... 507

Quality of non-sterile pharmaceutical preparations andsubstances for pharmaceutical use, microbiological (5.1.4.)(5.8.).................................................................................................. 623

Quantified hawthorn leaf and flower liquid extract............... 1150Quinidine sulfate............................................................................2833Quinine hydrochloride..................................................................2834Quinine sulfate ...............................................................................2835

RRabbit haemorrhagic disease vaccine (inactivated) ................. 933Rabies immunoglobulin, human ................................................ 2186Rabies vaccine for human use prepared in cell cultures......... 822Rabies vaccine (inactivated) for veterinary use......................... 934Rabies vaccine (live, oral) for foxes .............................................. 936Racecadotril ....................................................................................2841Racemic camphor...........................................................................1571Racemic ephedrine hydrochloride .............................................1928Racemic menthol ...........................................................................2445Raclopride ([11C]methoxy) injection............................................. 988Radionuclides, table of physical characteristics (5.7.) ............. 611Radiopharmaceutical preparations .............................................. 686Radiopharmaceutical preparations, iobenguane sulfate for ..982Radiopharmaceutical preparations, medronic acid for ........... 984Radiopharmaceutical preparations, pentetate sodium calciumfor ...................................................................................................... 987

Radiopharmaceutical preparations, tetra-O-acetyl-mannosetriflate for ......................................................................................1020

Raloxifene hydrochloride .............................................................2842Raman spectrometry (2.2.48.) ......................................................... 82Ramipril............................................................................................2843Ramon assay, flocculation value (Lf) of diphtheria and tetanustoxins and toxoids (2.7.27.) .......................................................... 231

Ranitidine hydrochloride..............................................................2845Rapeseed oil, refined.....................................................................2847Reagents (4.) ..................................................................................... 379Reagents (4.1.1.) ............................................................................... 379Reagents, standard solutions, buffer solutions (4.1.)............... 379Recombinant DNA technology, products of .............................. 692

Recommendations on dissolution testing (5.17.1.) ................... 665Recommendations on methods for dosage forms testing(5.17.) ................................................................................................ 665

Rectal capsules ................................................................................. 733Rectal foams...................................................................................... 733Rectal preparations.......................................................................... 732Rectal preparations, semi-solid ..................................................... 733Rectal solutions and suspensions, powders and tablets for ... 732Rectal solutions, emulsions and suspensions............................ 733Rectal tampons................................................................................. 734Red poppy petals............................................................................1222Reference standards (5.12.) ........................................................... 641Refractive index (2.2.6.) .................................................................... 26Relationship between reaction of solution, approximate pH andcolour of certain indicators (2.2.4.) ............................................. 25

Relative density (2.2.5.)..................................................................... 25Repaglinide......................................................................................2847Reserpine .........................................................................................2849Residual solvents (5.4.) ................................................................... 583Residual solvents, identification and control (2.4.24.) ............ 123Residue on evaporation of essential oils (2.8.9.)....................... 240Resistance to crushing of tablets (2.9.8.) ................................... 267Resorcinol ........................................................................................2850Restharrow root .............................................................................1223Retroviridae-derived vectors for human use .............................. 654Rhatany root ...................................................................................1223Rhatany tincture ............................................................................1224Rhinotracheitis vaccine (inactivated), viral, feline .................... 901Rhinotracheitis vaccine (live), viral, feline.................................. 902Rhubarb ...........................................................................................1224Ribavirin...........................................................................................2850Riboflavin.........................................................................................2852Riboflavin sodium phosphate......................................................2853Ribose in polysaccharide vaccines (2.5.31.) ............................... 146Ribwort plantain ............................................................................1225Rice starch.......................................................................................2855Rifabutin ..........................................................................................2855Rifampicin........................................................................................2856Rifamycin sodium...........................................................................2858Rifaximin..........................................................................................2859Rilmenidine dihydrogen phosphate...........................................2861Risperidone .....................................................................................2861Ritonavir ..........................................................................................2863Rocuronium bromide ....................................................................2866Roman chamomile flower ............................................................1098Ropivacaine hydrochloride monohydrate.................................2868Roselle ..............................................................................................1226Rosemary leaf .................................................................................1227Rosemary oil ...................................................................................1228Rotating viscometer method - viscosity (2.2.10.) ........................ 28Rotation, optical (2.2.7.) ................................................................... 26Rotavirus vaccine (live, oral) ......................................................... 824Roxithromycin.................................................................................2869RRR-α-Tocopherol ......................................................................... 3105RRR-α-Tocopheryl acetate ........................................................... 3108RRR-α-Tocopheryl hydrogen succinate .................................... 3111Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders(3.2.9.) .............................................................................................. 374

Rubella immunoglobulin, human............................................... 2187Rubella, measles and mumps vaccine (live) ............................... 798Rubella, measles, mumps and varicella vaccine (live).............. 799Rubella vaccine (live) ...................................................................... 827Rutoside trihydrate........................................................................2871

SSaccharin .........................................................................................2877Saccharin sodium ..........................................................................2878Safety, viral (5.1.7.) .......................................................................... 518Safflower flower .............................................................................1229Safflower oil, refined.....................................................................2879Saffron for homoeopathic preparations....................................1296



Sage leaf (salvia officinalis)..........................................................1230Sage leaf, three-lobed.................................................................... 1231Sage oil, Spanish............................................................................1239Sage tincture................................................................................... 1231Salbutamol ......................................................................................2879Salbutamol sulfate.........................................................................2881Salicylic acid....................................................................................2884Salmeterol xinafoate......................................................................2885Salmonella Enteritidis vaccine (inactivated) for chickens ...... 937Salmonella Typhimurium vaccine (inactivated) for chickens ..938Salmon oil, farmed.........................................................................2886Sanguisorba root............................................................................1232Saponification value (2.5.6.) .......................................................... 139Saquinavir mesilate .......................................................................2889Saw palmetto fruit .........................................................................1233Schisandra fruit..............................................................................1234Scopolamine.................................................................................... 2214Scopolamine butylbromide .......................................................... 2215Scopolamine hydrobromide......................................................... 2216Selamectin for veterinary use .....................................................2890Selegiline hydrochloride ..............................................................2892Selenium disulfide .........................................................................2893Semi-micro determination of water (2.5.12.) ............................. 140Semi-solid ear preparations ........................................................... 710Semi-solid eye preparations ........................................................... 712Semi-solid intrauterine preparations ........................................... 715Semi-solid nasal preparations........................................................ 721Semi-solid oromucosal preparations............................................ 722Semi-solid preparations for cutaneous application .................. 734Semi-solid rectal preparations....................................................... 733Semi-solid vaginal preparations.................................................... 740Senega root .....................................................................................1235Senna leaf ........................................................................................1236Senna leaf dry extract, standardised .........................................1237Senna pods, Alexandrian..............................................................1238Senna pods, Tinnevelly.................................................................1238Separation techniques, chromatographic (2.2.46.) .................... 70Serine................................................................................................2893Sertaconazole nitrate....................................................................2894Sertraline hydrochloride ..............................................................2895Sesame oil, refined ........................................................................2898Sets for the transfusion of blood and blood components(3.2.6.) .............................................................................................. 371

Sevoflurane .....................................................................................2899Shampoos .......................................................................................... 717Shellac .............................................................................................2901Shingles (herpes zoster) vaccine (live) ........................................ 828Sialic acid in polysaccharide vaccines (2.5.23.)......................... 143Siam benzoin tincture...................................................................1069Sieves (2.1.4.) .......................................................................................16Sieve test (2.9.12.)............................................................................ 270Sieving, analytical, particle-size distribution estimation by(2.9.38.) ............................................................................................ 313

Sieving, analytical, particle-size distribution estimation by(2.9.38.) (5.8.) ................................................................................. 623

SI (International System) units (1.) ..................................................3Silica, colloidal anhydrous ...........................................................2901Silica, colloidal hydrated ..............................................................2902Silica, dental type...........................................................................2903Silica, hydrophobic colloidal .......................................................2903Silicate, aluminium magnesium..................................................1358Silicate, aluminium sodium ......................................................... 1361Silicone elastomer for closures and tubing (3.1.9.) .................. 347Silicone oil used as a lubricant (3.1.8.) ....................................... 347Silk suture, sterile, braided, in distributor for veterinary use.........................................................................................................1039

Silver, colloidal, for external use ................................................2904Silver nitrate ...................................................................................2905Simeticone.......................................................................................2905Simvastatin......................................................................................2906Single-dose preparations, uniformity of content (2.9.6.)......... 266Single-dose preparations, uniformity of mass (2.9.5.).............. 265Sintered-glass filters (2.1.2.) ............................................................ 15

Size-exclusion chromatography (2.2.30.)...................................... 46(S)-Lactic acid..................................................................................2328Smallpox vaccine (live) ................................................................... 829Sodium acetate ([1-11C]) injection ................................................ 990Sodium acetate trihydrate ...........................................................2908Sodium alendronate ......................................................................2908Sodium alginate .............................................................................2909Sodium aluminium silicate .......................................................... 1361Sodium amidotrizoate................................................................... 2910Sodium aminosalicylate dihydrate ............................................. 2911Sodium ascorbate .......................................................................... 2912Sodium aurothiomalate................................................................ 2914Sodium benzoate ........................................................................... 2915Sodium bromide............................................................................. 2915Sodium calcium edetate ............................................................... 2916Sodium calcium pentetate for radiopharmaceuticalpreparations .................................................................................... 987

Sodium caprylate ........................................................................... 2917Sodium carbonate, anhydrous .................................................... 2918Sodium carbonate decahydrate .................................................. 2919Sodium carbonate monohydrate ................................................ 2919Sodium carboxymethylcellulose .................................................1589Sodium carboxymethylcellulose, cross-linked .........................1770Sodium carboxymethylcellulose, low-substituted...................1590Sodium cetostearyl sulfate ..........................................................2920Sodium chloride .............................................................................2921Sodium chromate (51Cr) sterile solution ..................................... 991Sodium citrate ................................................................................2922Sodium cromoglicate ....................................................................2923Sodium cyclamate..........................................................................2924Sodium dihydrogen phosphate dihydrate ................................2925Sodium ethyl parahydroxybenzoate .......................................... 1974Sodium fluoride .............................................................................2925Sodium fluoride (18F) injection ..................................................... 991Sodium fusidate .............................................................................2926Sodium glycerophosphate, hydrated .........................................2927Sodium hyaluronate ......................................................................2927Sodium hydrogen carbonate .......................................................2929Sodium hydroxide..........................................................................2930Sodium iodide.................................................................................2930Sodium iodide (123I) injection ........................................................ 992Sodium iodide (123I) solution for radiolabelling ........................ 993Sodium iodide (131I) capsules for diagnostic use....................... 994Sodium iodide (131I) capsules for therapeutic use .................... 995Sodium iodide (131I) solution ......................................................... 996Sodium iodide (131I) solution for radiolabelling ........................ 996Sodium iodohippurate (123I) injection ......................................... 997Sodium iodohippurate (131I) injection ......................................... 998Sodium lactate solution................................................................2931Sodium laurilsulfate ......................................................................2933Sodium metabisulfite ....................................................................2933Sodium methyl parahydroxybenzoate.......................................2934Sodium molybdate (99Mo) solution (fission) .............................. 999Sodium molybdate dihydrate ......................................................2935Sodium nitrite.................................................................................2936Sodium nitroprusside ...................................................................2936Sodium perborate, hydrated........................................................2937Sodium pertechnetate (99mTc) injection (fission) .................... 1001Sodium pertechnetate (99mTc) injection (non-fission) ............1002Sodium phenylbutyrate ................................................................2938Sodium phosphate (32P) injection ..............................................1003Sodium picosulfate ........................................................................2939Sodium polystyrene sulfonate.....................................................2940Sodium propionate ........................................................................2941Sodium propyl parahydroxybenzoate........................................2942Sodium salicylate ...........................................................................2943Sodium selenite pentahydrate ....................................................2944Sodium (S)-lactate solution .........................................................2932Sodium starch glycolate (type A) ...............................................2944Sodium starch glycolate (type B) ...............................................2945Sodium starch glycolate (type C) ...............................................2946Sodium stearate .............................................................................2947Sodium stearyl fumarate ..............................................................2948



Sodium sulfate, anhydrous ..........................................................2948Sodium sulfate decahydrate ........................................................2949Sodium sulfite, anhydrous ...........................................................2950Sodium sulfite heptahydrate .......................................................2950Sodium thiosulfate ........................................................................2951Sodium valproate ...........................................................................2951Soft capsules ..................................................................................... 708Softening time determination of lipophilic suppositories(2.9.22.) ............................................................................................ 288

Soft extracts ...................................................................................... 676Solid dosage forms, dissolution test for (2.9.3.)........................ 256Solid dosage forms, recommendations on dissolution testing of(5.17.1.)............................................................................................. 665

Solids by mercury porosimetry, porosity and pore-sizedistribution of (2.9.32.)................................................................. 299

Solids, density of (2.2.42.) ................................................................ 66Solids, gas pycnometric density of (2.9.23.)............................... 288Solids (porous) including powders, wettability of (2.9.45.) .... 321Solubility in alcohol of essential oils (2.8.10.) ........................... 240Soluble tablets .................................................................................. 737Solutions, emulsions and suspensions, oral .............................. 718Solutions for haemodialysis......................................................... 2136Solutions for haemodialysis, concentrated, water fordiluting........................................................................................... 2135

Solutions for haemofiltration and haemodiafiltration........... 2138Solutions for organ preservation................................................2952Solutions for peritoneal dialysis .................................................2695Solutions, suspensions, intrauterine ........................................... 715Solvents, residual (5.4.) .................................................................. 583Solvents, residual, identification and control (2.4.24.) ............ 123Somatostatin ...................................................................................2953Somatropin......................................................................................2954Somatropin concentrated solution ............................................2956Somatropin for injection ..............................................................2958Sorbic acid.......................................................................................2960Sorbitan laurate .............................................................................2961Sorbitan oleate ...............................................................................2961Sorbitan palmitate .........................................................................2962Sorbitan sesquioleate....................................................................2962Sorbitan stearate............................................................................2962Sorbitan trioleate ...........................................................................2963Sorbitol.............................................................................................2963Sorbitol, liquid (crystallising)......................................................2965Sorbitol, liquid (non-crystallising)..............................................2965Sorbitol, liquid, partially dehydrated.........................................2966Sotalol hydrochloride ...................................................................2967Soya-bean oil, hydrogenated........................................................2968Soya-bean oil, refined....................................................................2969Spanish sage oil..............................................................................1239Specific surface area by air permeability (2.9.14.).................... 271Specific surface area by gas adsorption (2.9.26.) ..................... 291Specific surface area by gas adsorption (2.9.26.) (5.8.)........... 622Spectinomycin dihydrochloride pentahydrate ........................2969Spectinomycin sulfate tetrahydrate for veterinary use .........2971Spectrometry, atomic absorption (2.2.23.)................................... 36Spectrometry, atomic emission (2.2.22.)....................................... 35Spectrometry, mass (2.2.43.) ........................................................... 67Spectrometry, nuclear magnetic resonance (2.2.33.) ................ 52Spectrometry, Raman (2.2.48.) ....................................................... 82Spectrometry, X-ray fluorescence (2.2.37.)................................... 58Spectrophotometry, infrared absorption (2.2.24.)...................... 38Spectrophotometry, near-infrared (2.2.40.)...................................61Spectrophotometry, ultraviolet and visible absorption(2.2.25.) .............................................................................................. 40

SPF chicken flocks for the production and quality control ofvaccines (5.2.2.) .............................................................................. 527

Spheroids and granules, friability of (2.9.41.)............................ 318Spike lavender oil ..........................................................................1240Spiramycin.......................................................................................2973Spirapril hydrochloride monohydrate.......................................2975Spironolactone ...............................................................................2976Spot-on preparations....................................................................... 740Sprays ................................................................................................. 740

Sprays (liquid nasal) and drops (nasal) ....................................... 720Squalane ..........................................................................................2978Standard solutions for limit tests (4.1.2.) ................................... 485Standards, reference (5.12.)........................................................... 641Stannous chloride dihydrate .......................................................2980Stanozolol........................................................................................2981Star anise .........................................................................................1244Star anise oil ...................................................................................1245Starches, hydroxyethyl..................................................................2984Starch glycolate (type A), sodium ..............................................2944Starch glycolate (type B), sodium ..............................................2945Starch glycolate (type C), sodium ..............................................2946Starch, hydroxypropyl...................................................................2981Starch, maize ..................................................................................2422Starch, potato .................................................................................2775Starch, pregelatinised ...................................................................2983Starch, rice ......................................................................................2855Starch, wheat ..................................................................................3226Starflower (borage) oil, refined...................................................1503Statistical analysis of results of biological assays and tests(5.3.).................................................................................................. 551

Stavudine.........................................................................................2988Steam sterilisation of aqueous preparations, application of theF0 concept (5.1.5.).......................................................................... 508

Stearic acid......................................................................................2989Stearoyl macrogolglycerides .......................................................2990Stearyl alcohol................................................................................2991Stem cells, human haematopoietic ............................................ 2175Stephania root, fourstamen.........................................................1127Sterile braided silk suture in distributor for veterinary use ..1039Sterile catgut...................................................................................1027Sterile catgut in distributor for veterinary use .......................1037Sterile containers of plasticised poly(vinyl chloride) for humanblood containing anticoagulant solution (3.2.5.) ................... 371

Sterile linen thread in distributor for veterinary use ............1038Sterile non-absorbable strands in distributor for veterinaryuse...................................................................................................1039

Sterile non-absorbable sutures ...................................................1028Sterile plastic containers for human blood and bloodcomponents (3.2.3.) ....................................................................... 369

Sterile polyamide 6/6 suture in distributor for veterinaryuse...................................................................................................1038

Sterile polyamide 6 suture in distributor for veterinaryuse...................................................................................................1038

Sterile poly(ethylene terephthalate) suture in distributor forveterinary use ...............................................................................1039

Sterile products, methods of preparation (5.1.1.) ..................... 503Sterile single-use plastic syringes (3.2.8.) ................................... 373Sterile synthetic absorbable braided sutures .......................... 1031Sterile synthetic absorbable monofilament sutures...............1033Sterilisation procedures, biological indicators (5.1.2.) ............ 504Sterility (2.6.1.) ................................................................................. 153Sterility, guidelines for using the test for (5.1.9.) ..................... 519Sterols in fatty oils (2.4.23.)........................................................... 121Sticks .................................................................................................. 736Sticks, intrauterine .......................................................................... 715Sticks, nasal....................................................................................... 721St. John’s wort................................................................................1241St. John’s wort dry extract, quantified......................................1242Stomata and stomatal index (2.8.3.) ............................................ 239Stramonium leaf.............................................................................1247Stramonium, prepared ..................................................................1248Strands, sterile non-absorbable, in distributor for veterinary use.........................................................................................................1039

Streptokinase concentrated solution ........................................2991Streptomycin sulfate .....................................................................2993Strontium (89Sr) chloride injection ............................................1003Subdivision of tablets...................................................................... 736Sublingual sprays, oromucosal drops and oromucosalsprays................................................................................................ 721

Sublingual tablets and buccal tablets ......................................... 723Substances for pharmaceutical use ............................................. 694



Substances for pharmaceutical use, control of impurities in(5.10.)................................................................................................ 631

Substances of animal origin for the production of immunologicalveterinary medicinal products (5.2.5.) ...................................... 535

Sub-visible particles, particulate contamination (2.9.19.)....... 285Succinylsulfathiazole ....................................................................2994Sucralfate.........................................................................................2995Sucrose.............................................................................................2996Sucrose monopalmitate................................................................2998Sucrose stearate .............................................................................2999Sufentanil ........................................................................................3000Sufentanil citrate ...........................................................................3001Sugars, lead in (2.4.10.) ...................................................................117Sugar spheres .................................................................................3002Sulbactam sodium .........................................................................3003Sulfacetamide sodium...................................................................3005Sulfadiazine.....................................................................................3006Sulfadimidine..................................................................................3007Sulfadoxine......................................................................................3007Sulfafurazole...................................................................................3008Sulfaguanidine................................................................................3009Sulfamerazine................................................................................. 3010Sulfamethizole................................................................................ 3011Sulfamethoxazole .......................................................................... 3011Sulfamethoxypyridazine for veterinary use ............................. 3013Sulfanilamide .................................................................................. 3013Sulfasalazine ................................................................................... 3014Sulfated ash (2.4.14.)....................................................................... 118Sulfated ash (2.4.14.) (5.8.)............................................................ 622Sulfates (2.4.13.)............................................................................... 118Sulfathiazole ................................................................................... 3016Sulfinpyrazone ............................................................................... 3017Sulfisomidine .................................................................................. 3018Sulfur dioxide (2.5.29.) ................................................................... 145Sulfur for external use.................................................................. 3019Sulfuric acid .................................................................................... 3019Sulindac ...........................................................................................3020Sulpiride...........................................................................................3021Sultamicillin ....................................................................................3022Sultamicillin tosilate dihydrate...................................................3024Sumatra benzoin............................................................................1068Sumatra benzoin tincture ............................................................1069Sumatriptan succinate..................................................................3026Sunflower oil, refined ...................................................................3028Supercritical fluid chromatography (2.2.45.) .............................. 70Suppositories .................................................................................... 733Suppositories and pessaries, disintegration of (2.9.2.)............ 255Suppositories, lipophilic, softening time determination(2.9.22.) ............................................................................................ 288

Suspensions, solutions and emulsions, oral .............................. 718Suspensions, solutions, intrauterine ........................................... 715Sutures, sterile non-absorbable ..................................................1028Sutures, sterile synthetic absorbable braided ........................ 1031Sutures, sterile synthetic absorbable monofilament ............1033Suxamethonium chloride.............................................................3028Suxibuzone......................................................................................3029Sweet fennel ....................................................................................1125Sweet orange oil.............................................................................1249Swelling index (2.8.4.)..................................................................... 239Swine erysipelas vaccine (inactivated) ........................................ 939Swine-fever vaccine (live, prepared in cell cultures),classical ............................................................................................ 940

Symbols and abbreviations (1.) ..........................................................3Synthetic absorbable braided sutures, sterile ......................... 1031Synthetic absorbable monofilament sutures, sterile..............1033Syringes, plastic, sterile single-use (3.2.8.) ................................. 373Syrups................................................................................................. 719

TTable of physical characteristics of radionuclides mentioned inthe European Pharmacopoeia (5.7.).......................................... 611

Tablets ................................................................................................ 736

Tablets and capsules, disintegration of (2.9.1.) ......................... 253Tablets, buccal .................................................................................. 723Tablets, coated.................................................................................. 737Tablets, dispersible .......................................................................... 737Tablets, effervescent ........................................................................ 737Tablets for intrauterine solutions and suspensions ................. 715Tablets for use in the mouth ......................................................... 738Tablets for vaginal solutions and suspensions .......................... 739Tablets, gastro-resistant.................................................................. 738Tablets, intrauterine ........................................................................ 715Tablets, modified-release ................................................................ 738Tablets, orodispersible .................................................................... 737Tablets, resistance to crushing (2.9.8.) ....................................... 267Tablets, soluble................................................................................. 737Tablets, subdivision of .................................................................... 736Tablets, sublingual........................................................................... 723Tablets, uncoated ............................................................................. 737Tablets, uncoated, friability of (2.9.7.) ......................................... 266Tablets, uncoated, friability of (2.9.7.) (5.8.) .............................. 622Tablets, vaginal................................................................................. 739Talc....................................................................................................3033Tamoxifen citrate ...........................................................................3034Tampons, ear..................................................................................... 710Tampons, medicated ....................................................................... 738Tampons, rectal ................................................................................ 734Tampons, vaginal, medicated ........................................................ 740Tamsulosin hydrochloride ...........................................................3036Tannic acid ......................................................................................3037Tannins in herbal drugs, determination of (2.8.14.) ................ 243Tapped density of powders, bulk density and (2.9.34.) ........... 305Tartaric acid ....................................................................................3038Teat dips............................................................................................. 740Tea tree oil ....................................................................................... 1251Teat sprays..........................................................................................741Technetium (99mTc) bicisate injection ........................................1004Technetium (99mTc) colloidal rhenium sulfide injection .......1005Technetium (99mTc) colloidal sulfur injection...........................1006Technetium (99mTc) colloidal tin injection ................................1006Technetium (99mTc) etifenin injection ........................................1007Technetium (99mTc) exametazime injection ..............................1008Technetium (99mTc) gluconate injection ....................................1009Technetium (99mTc) human albumin injection ......................... 1010Technetium (99mTc) macrosalb injection.................................... 1011Technetium (99mTc) mebrofenin injection ................................. 1012Technetium (99mTc) medronate injection................................... 1013Technetium (99mTc) mertiatide injection ................................... 1014Technetium (99mTc) microspheres injection.............................. 1015Technetium (99mTc) pentetate injection..................................... 1016Technetium (99mTc) sestamibi injection ..................................... 1017Technetium (99mTc) succimer injection...................................... 1018Technetium (99mTc) tin pyrophosphate injection..................... 1019Teicoplanin ......................................................................................3038Telmisartan......................................................................................3040Temazepam......................................................................................3042Tenosynovitis avian viral vaccine (live) ....................................... 861Tenoxicam........................................................................................3043Terazosin hydrochloride dihydrate ............................................3045Terbinafine hydrochloride............................................................3047Terbutaline sulfate.........................................................................3048Terconazole .....................................................................................3049Terfenadine......................................................................................3050Terminology used in monographs on biological products(5.2.1.)............................................................................................... 527

Test for anticomplementary activity of immunoglobulin(2.6.17.)............................................................................................. 177

Test for anti-D antibodies in human immunoglobulin forintravenous administration (2.6.26.) ......................................... 191

Test for aristolochic acids in herbal drugs (2.8.21) .................. 247Test for extractable volume of parenteral preparations(2.9.17.)............................................................................................. 273

Test for extractable volume of parenteral preparations (2.9.17.)(5.8.).................................................................................................. 622

Test for Fc function of immunoglobulin (2.7.9.) ........................217



Test for methanol and 2-propanol (2.9.11.) ................................ 270Test for neurovirulence of live virus vaccines (2.6.18.) ........... 179Test for neurovirulence of poliomyelitis vaccine (oral)(2.6.19.) ............................................................................................ 179

Test for specified micro-organisms (microbiological examinationof non-sterile products) (2.6.13.) ................................................ 167

Test for specified micro-organisms (microbiological examinationof non-sterile products) (2.6.13.) (5.8.) ..................................... 622

Testosterone ....................................................................................3052Testosterone decanoate ................................................................3053Testosterone enantate...................................................................3054Testosterone isocaproate..............................................................3056Testosterone propionate...............................................................3057Tests for extraneous agents in viral vaccines for human use(2.6.16.) ............................................................................................ 176

Tetanus and diphtheria toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.) ................................................... 231

Tetanus and diphtheria vaccine (adsorbed, reduced antigen(s)content)............................................................................................ 752

Tetanus antitoxin for human use ................................................. 953Tetanus antitoxin for veterinary use............................................ 960Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed)........................................................................................ 753

Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed)......................................................................... 754

Tetanus, diphtheria and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .................................... 756

Tetanus, diphtheria, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ................ 758

Tetanus, diphtheria, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ..................................... 760

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed) ........................ 762

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ........................................................................ 763

Tetanus, diphtheria, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) ......................................... 765

Tetanus, diphtheria, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed)......................................................................... 768

Tetanus, diphtheria, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)......................................................................... 771

Tetanus, diphtheria, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ................ 772

Tetanus immunoglobulin, human .............................................. 2187Tetanus vaccine (adsorbed) ........................................................... 833Tetanus vaccine (adsorbed), assay of (2.7.8.) ............................. 214Tetanus vaccine for veterinary use .............................................. 941Tetracaine hydrochloride .............................................................3058Tetracosactide.................................................................................3059Tetracycline .....................................................................................3060Tetracycline hydrochloride ..........................................................3061Tetra-O-acetyl-mannose triflate for radiopharmaceuticalpreparations..................................................................................1020

Tetrazepam......................................................................................3063Tetryzoline hydrochloride............................................................3064Thallous (201Tl) chloride injection............................................... 1021Theobromine...................................................................................3065Theophylline ...................................................................................3065Theophylline-ethylenediamine, anhydrous...............................3068Theophylline-ethylenediamine hydrate .....................................3069Theophylline monohydrate..........................................................3066Thermal analysis (2.2.34.) ................................................................ 54Thermogravimetry (2.2.34.) ............................................................. 54Thiamazole ......................................................................................3071Thiamine hydrochloride ...............................................................3072Thiamine nitrate.............................................................................3073Thiamphenicol ................................................................................3074Thin-layer chromatography (2.2.27.).............................................. 42Thioctic acid ....................................................................................3075Thiomersal.......................................................................................3076

Thiopental sodium and sodium carbonate...............................3077Thioridazine ....................................................................................3078Thioridazine hydrochloride .........................................................3079Three-lobed sage leaf..................................................................... 1231Threonine.........................................................................................3080Thyme ...............................................................................................1252Thyme oil ........................................................................................1254Thyme, wild .....................................................................................1267Thymol..............................................................................................3081Tiabendazole ...................................................................................3081Tiamulin for veterinary use .........................................................3082Tiamulin hydrogen fumarate for veterinary use .....................3084Tianeptine sodium .........................................................................3086Tiapride hydrochloride .................................................................3087Tiaprofenic acid ..............................................................................3088Tibolone ...........................................................................................3090Ticarcillin sodium...........................................................................3091Tick-borne encephalitis vaccine (inactivated) ............................ 834Ticlopidine hydrochloride ............................................................3092Tilidine hydrochloride hemihydrate ..........................................3094Timolol maleate ..............................................................................3095Tinctures ............................................................................................ 675Tinidazole ........................................................................................3097Tinnevelly senna pods...................................................................1238Tinzaparin sodium.........................................................................3098Tioconazole .....................................................................................3099Tiotropium bromide monohydrate............................................. 3100Titanium dioxide ............................................................................ 3101Titration, amperometric (2.2.19.).................................................... 34Titration, potentiometric (2.2.20.) .................................................. 34Titrations, complexometric (2.5.11.) ............................................ 140Tobramycin ...................................................................................... 3103Tocopherol, all-rac-α- .................................................................... 3104Tocopherol, RRR-α- ....................................................................... 3105Tocopheryl acetate, all-rac-α- ...................................................... 3106α-Tocopheryl acetate concentrate (powder form) .................. 3109Tocopheryl acetate, RRR-α-......................................................... 3108Tocopheryl hydrogen succinate, DL-α- ...................................... 3110Tocopheryl hydrogen succinate, RRR-α- .................................. 3111Tolbutamide .................................................................................... 3113Tolfenamic acid............................................................................... 3114Tolnaftate......................................................................................... 3115Tolu balsam .....................................................................................1254Torasemide, anhydrous................................................................. 3117Tormentil .........................................................................................1255Tormentil tincture..........................................................................1256Tosylchloramide sodium............................................................... 3118Total ash (2.4.16.)............................................................................. 118Total cholesterol in oils rich in omega-3 acids (2.4.32.) .......... 133Total organic carbon in water for pharmaceutical use(2.2.44.) .............................................................................................. 69

Total protein (2.5.33.) ..................................................................... 147Toxicity, abnormal (2.6.9.).............................................................. 162Toxin, botulinum type A for injection .......................................1504Tragacanth ......................................................................................1256Tramadol hydrochloride ............................................................... 3118Tramazoline hydrochloride monohydrate ................................ 3120Trandolapril..................................................................................... 3120Tranexamic acid ............................................................................. 3122Transdermal patches ....................................................................... 726Transdermal patches, dissolution test for (2.9.4.) .................... 263Trapidil ............................................................................................. 3123Trehalose dihydrate....................................................................... 3124Tretinoin .......................................................................................... 3125Triacetin ........................................................................................... 3127Triamcinolone................................................................................. 3127Triamcinolone acetonide.............................................................. 3128Triamcinolone hexacetonide ....................................................... 3130Triamterene ..................................................................................... 3131Tribenoside...................................................................................... 3132Tributyl acetylcitrate ..................................................................... 3133Trichloroacetic acid ....................................................................... 3135Triethanolamine ............................................................................. 3148



Triethyl citrate ................................................................................ 3136Trifluoperazine hydrochloride .................................................... 3136Triflusal ............................................................................................ 3137Triglycerides, medium-chain........................................................ 3138Triglycerides, omega-3-acid.......................................................... 2619Triglycerol diisostearate ............................................................... 3140Trihexyphenidyl hydrochloride................................................... 3140Trimebutine maleate ..................................................................... 3141Trimetazidine dihydrochloride.................................................... 3142Trimethadione ................................................................................ 3144Trimethoprim.................................................................................. 3144Trimipramine maleate ................................................................... 3146Tri-n-butyl phosphate .................................................................... 3134Tritiated (3H) water injection.......................................................1022Trolamine......................................................................................... 3148Trometamol ..................................................................................... 3150Tropicamide..................................................................................... 3151Tropisetron hydrochloride ........................................................... 3152Trospium chloride.......................................................................... 3154Troxerutin........................................................................................ 3155Trypsin ............................................................................................. 3156Tryptophan...................................................................................... 3157TSE, animal, minimising the risk of transmitting via human andveterinary medicinal products (5.2.8.) ...................................... 539

TSE, animal, products with risk of transmitting agents of..... 686Tuberculin for human use, old.................................................... 3159Tuberculin purified protein derivative, avian .......................... 3161Tuberculin purified protein derivative, bovine........................ 3161Tuberculin purified protein derivative for human use .......... 3162Tubes for comparative tests (2.1.5.) ................................................17Tubing and closures, silicone elastomer for (3.1.9.)................. 347Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ......... 345

Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinyl chloride)for (3.1.1.2.) ..................................................................................... 332

Tubocurarine chloride .................................................................. 3164Turmeric, Javanese ........................................................................1257Turpentine oil, Pinus pinaster type ...........................................1258Tylosin for veterinary use ............................................................ 3165Tylosin phosphate bulk solution for veterinary use .............. 3166Tylosin tartrate for veterinary use ............................................. 3168Typhoid polysaccharide vaccine ................................................... 836Typhoid vaccine................................................................................ 837Typhoid vaccine, freeze-dried........................................................ 837Typhoid vaccine (live, oral, strain Ty 21a).................................. 838Tyrosine............................................................................................ 3169Tyrothricin....................................................................................... 3170

UUbidecarenone................................................................................ 3175Udder-washes .....................................................................................741Ultraviolet and visible absorption spectrophotometry(2.2.25.) .............................................................................................. 40

Ultraviolet ray lamps for analytical purposes (2.1.3.)................. 15Uncoated tablets............................................................................... 737Undecylenic acid ............................................................................ 3176Uniformity of content of single-dose preparations (2.9.6.) ..... 266Uniformity of dosage units (2.9.40.) ............................................ 315Uniformity of mass of delivered doses from multidose containers(2.9.27.) ............................................................................................ 294

Uniformity of mass of single-dose preparations (2.9.5.) .......... 265Units of the International System (SI) used in the Pharmacopoeiaand equivalence with other units (1.).............................................3

Unsaponifiable matter (2.5.7.) ....................................................... 139Urea................................................................................................... 3176Urofollitropin .................................................................................. 3177Urokinase......................................................................................... 3178Uronic acids in polysaccharide vaccines (2.5.22.)..................... 143Ursodeoxycholic acid ................................................................... 3180

VVaccines, adsorbed, aluminium in (2.5.13.).................................141Vaccines, adsorbed, calcium in (2.5.14.).......................................141Vaccines and immunosera, phenol in (2.5.15.) ...........................141Vaccines and immunosera, veterinary, evaluation of efficacy of(5.2.7.)............................................................................................... 538

Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) .............................................................................................. 536

Vaccines and immunosera, veterinary, evaluation of the safetyof each batch (5.2.9.)..................................................................... 547

Vaccines for human use.................................................................. 695Vaccines for human use, cell substrates for the production of(5.2.3.) .............................................................................................. 530

Vaccines for human use, viral, tests for extraneous agents in(2.6.16.) ............................................................................................ 176

Vaccines for veterinary use............................................................ 698Vaccines, polysaccharide, hexosamines in (2.5.20.).................. 142Vaccines, polysaccharide, methylpentoses in (2.5.21.)............. 143Vaccines, polysaccharide, nucleic acids in (2.5.17.) .................. 142Vaccines, polysaccharide, O-acetyl in (2.5.19.)........................... 142Vaccines, polysaccharide, phosphorus in (2.5.18.) ................... 142Vaccines, polysaccharide, protein in (2.5.16.) .............................141Vaccines, polysaccharide, ribose in (2.5.31.) .............................. 146Vaccines, polysaccharide, sialic acid in (2.5.23.) ....................... 143Vaccines, polysaccharide, uronic acids in (2.5.22.)................... 143Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) .......................................................................... 527

Vaccines, veterinary, cell cultures for the production of(5.2.4.) .............................................................................................. 533

Vaccines, viral live, test for neurovirulence (2.6.18.)................ 179Vaginal capsules ............................................................................... 739Vaginal foams.................................................................................... 740Vaginal preparations ....................................................................... 738Vaginal preparations, semi-solid ................................................... 740Vaginal solutions and suspensions, tablets for ......................... 739Vaginal solutions, emulsions and suspensions.......................... 739Vaginal tablets .................................................................................. 739Vaginal tampons, medicated.......................................................... 740Valaciclovir hydrochloride, anhydrous...................................... 3185Valerian dry aqueous extract .....................................................1259Valerian dry hydroalcoholic extract...........................................1260Valerian root....................................................................................1261Valerian root, cut............................................................................1262Valerian tincture.............................................................................1263Validation of nucleic acid amplification techniques forthe detection of B19 virus (B19V) DNA in plasma pools :guidelines ........................................................................................ 181

Validation of nucleic acid amplification techniques for thedetection of hepatitis C virus (HCV) RNA in plasma pools :guidelines ........................................................................................ 181

Valine ................................................................................................ 3188Valnemulin hydrochloride for veterinary use ......................... 3188Valproate, sodium ..........................................................................2951Valproic acid.................................................................................... 3190Valsartan .......................................................................................... 3191Vancomycin hydrochloride .......................................................... 3192Vanillin ............................................................................................. 3194Varicella immunoglobulin for intravenous administration,human ............................................................................................ 2189

Varicella immunoglobulin, human............................................. 2188Varicella, measles, mumps and rubella vaccine (live) .............. 799Varicella vaccine (live)..................................................................... 839Vectors for human use, adenovirus ............................................. 650Vectors for human use, plasmid ................................................... 648Vectors for human use, plasmid, bacterial cells used for themanufacture of ............................................................................... 649

Vectors for human use, poxvirus .................................................. 652Vecuronium bromide..................................................................... 3195Vedaprofen for veterinary use..................................................... 3196Vegetable fatty oils........................................................................... 703Venlafaxine hydrochloride ........................................................... 3197Verapamil hydrochloride .............................................................. 3198

General Notices (1) apply to all monographs and other texts 3294a


Verbena herb...................................................................................1264Veterinary liquid preparations for cutaneous application ...... 740Veterinary medicinal products, immunological, substances ofanimal origin for the production of (5.2.5.) ............................. 535

Veterinary vaccines and immunosera, evaluation of efficacy of(5.2.7.)............................................................................................... 538

Viability, nucleated cell count and (2.7.29.) ............................... 233Vibriosis (cold-water) vaccine (inactivated) for salmonids ...... 943Vibriosis vaccine (inactivated) for salmonids............................. 944VICH (5.8.) ......................................................................................... 621Vinblastine sulfate .........................................................................3200Vincristine sulfate ..........................................................................3201Vindesine sulfate ............................................................................3202Vinorelbine tartrate .......................................................................3204Vinpocetine......................................................................................3206Viper venom antiserum, European .............................................. 953Viral rhinotracheitis vaccine (inactivated), feline...................... 901Viral rhinotracheitis vaccine (live), feline ................................... 902Viral safety (5.1.7.) ........................................................................... 518Viral vaccines for human use, tests for extraneous agents in(2.6.16.) ............................................................................................ 176

Viscometer method, capillary (2.2.9.) ............................................ 27Viscometer method, falling ball (2.2.49.) ...................................... 83Viscose wadding, absorbent ........................................................3207Viscosity (2.2.8.) ................................................................................. 27Viscosity - rotating viscometer method (2.2.10.) ......................... 28Visible and ultraviolet absorption spectrophotometry(2.2.25.) .............................................................................................. 40

Visible particles, particulate contamination (2.9.20.) .............. 287Vitamin A .........................................................................................3208Vitamin A concentrate (oily form), synthetic ...........................3209Vitamin A concentrate (powder form), synthetic .................... 3211Vitamin A concentrate (solubilisate/emulsion), synthetic ...3212Volumetric analysis (4.2.) ............................................................... 494Volumetric solutions (4.2.2.).......................................................... 494Volumetric solutions, primary standards for (4.2.1.) ............... 494von Willebrand factor, human .................................................... 2189von Willebrand factor, human, assay of (2.7.21.) ...................... 226

WWarfarin sodium............................................................................. 3217Warfarin sodium clathrate ........................................................... 3218Washes, nasal.................................................................................... 721Water (15O) injection......................................................................1023Water, determination by distillation (2.2.13.) ...............................31Water for diluting concentrated haemodialysis solutions .... 2135Water for injections ....................................................................... 3219Water for pharmaceutical use, total organic carbon in(2.2.44.) .............................................................................................. 69

Water, highly purified ...................................................................3222Water in essential oils (2.8.5.) ....................................................... 239Water in gases (2.5.28.) .................................................................. 145Water : micro determination (2.5.32.) .......................................... 146Water, purified................................................................................3224

Water : semi-micro determination (2.5.12.)................................. 140Wettability of porous solids including powders (2.9.45.)........ 321Wheat-germ oil, refined ................................................................3226Wheat-germ oil, virgin...................................................................3227Wheat starch ...................................................................................3226White beeswax ................................................................................1453White horehound...........................................................................1265White soft paraffin.........................................................................2670Wild pansy (flowering aerial parts)............................................1266Wild thyme ......................................................................................1267Willow bark .....................................................................................1268Willow bark dry extract ................................................................1269Wool alcohols..................................................................................3227Wool fat ............................................................................................3228Wool fat, hydrogenated.................................................................3232Wool fat, hydrous...........................................................................3233Wormwood ......................................................................................1270

XXanthan gum ..................................................................................3237Xenon (133Xe) injection..................................................................1023X-ray fluorescence spectrometry (2.2.37.)..................................... 58X-ray powder diffraction (XRPD), characterisation of crystallineand partially crystalline solids by (2.9.33.) .............................. 301

Xylazine hydrochloride for veterinary use ...............................3238Xylitol ................................................................................................3239Xylometazoline hydrochloride ....................................................3241Xylose................................................................................................3242

YYarrow ..............................................................................................1271Yellow beeswax ...............................................................................1454Yellow fever vaccine (live) .............................................................. 840Yellow soft paraffin........................................................................2671Yohimbine hydrochloride .............................................................3247

ZZidovudine.......................................................................................3251Zinc acetate dihydrate...................................................................3252Zinc acexamate ...............................................................................3253Zinc chloride ...................................................................................3254Zinc gluconate ................................................................................3255Zinc oxide.........................................................................................3255Zinc stearate....................................................................................3256Zinc sulfate heptahydrate.............................................................3257Zinc sulfate hexahydrate ..............................................................3257Zinc sulfate monohydrate.............................................................3257Zinc undecylenate ..........................................................................3258Ziprasidone hydrochloride monohydrate .................................3258Zolpidem tartrate ...........................................................................3260Zopiclone .........................................................................................3261Zoster (shingles) vaccine (live), herpes ....................................... 828Zuclopenthixol decanoate ............................................................3263

3294b See the information section on general monographs (cover pages)


Numericsα-1-Proteinasi inhibitor humanum ......................................... 2184

AAbsinthii herba ..............................................................................1270Acaciae gummi ..............................................................................1043Acaciae gummi dispersione desiccatum................................. 1301Acamprosatum calcicum............................................................. 1301Acarbosum ......................................................................................1302Acebutololi hydrochloridum ......................................................1304Aceclofenacum...............................................................................1306Acemetacinum ...............................................................................1307Acesulfamum kalicum .................................................................1309Acetazolamidum............................................................................ 1310Acetonum ........................................................................................ 1312Acetylcholini chloridum .............................................................. 1313Acetylcysteinum ............................................................................ 1313β-Acetyldigoxinum ........................................................................ 1315Aciclovirum .................................................................................... 1321Acidi methacrylici et ethylis acrylatis polymerisati 1:1dispersio 30 per centum ...........................................................2460

Acidi methacrylici et ethylis acrylatis polymerisatum1:1 ...................................................................................................2459

Acidi methacrylici et methylis methacrylatis polymerisatum1:1 ...................................................................................................2461

Acidi methacrylici et methylis methacrylatis polymerisatum1:2 ...................................................................................................2461

Acidum 4-aminobenzoicum .......................................................1371Acidum aceticum glaciale........................................................... 1311Acidum acetylsalicylicum ........................................................... 1317Acidum adipicum ..........................................................................1328Acidum alginicum.........................................................................1342Acidum amidotrizoicum dihydricum ......................................1366Acidum aminocaproicum ...........................................................1373Acidum ascorbicum ...................................................................... 1418Acidum asparticum ......................................................................1423Acidum benzoicum .......................................................................1467Acidum boricum ............................................................................1504Acidum caprylicum ......................................................................1571Acidum chenodeoxycholicum....................................................1650Acidum citricum anhydricum ...................................................1705Acidum citricum monohydricum .............................................1706Acidum edeticum .......................................................................... 1912Acidum etacrynicum ....................................................................1960Acidum folicum .............................................................................2065Acidum fusidicum .........................................................................2079Acidum glutamicum ..................................................................... 2105Acidum hydrochloridum concentratum.................................. 2192Acidum hydrochloridum dilutum ............................................. 2192Acidum iopanoicum .....................................................................2268Acidum iotalamicum ....................................................................2272Acidum ioxaglicum.......................................................................2275Acidum lacticum ...........................................................................2328Acidum lactobionicum.................................................................2331Acidum maleicum .........................................................................2424Acidum malicum ...........................................................................2424Acidum medronicum ad radiopharmaceutica ........................ 984Acidum mefenamicum.................................................................2438Acidum nalidixicum .....................................................................2547Acidum nicotinicum.....................................................................2570Acidum niflumicum .....................................................................2572Acidum nitricum ...........................................................................2581Acidum oleicum............................................................................. 2610Acidum oxolinicum ......................................................................2642Acidum palmiticum ......................................................................2660Acidum phosphoricum concentratum .....................................2725Acidum phosphoricum dilutum ................................................2725Acidum pipemidicum trihydricum ...........................................2737Acidum salicylicum ......................................................................2884Acidum (S)-lacticum .....................................................................2328Acidum sorbicum ..........................................................................2960Acidum stearicum .........................................................................2989

Acidum sulfuricum ....................................................................... 3019Acidum tartaricum .......................................................................3038Acidum thiocticum........................................................................3075Acidum tiaprofenicum .................................................................3088Acidum tolfenamicum.................................................................. 3114Acidum tranexamicum ................................................................ 3122Acidum trichloraceticum ............................................................ 3135Acidum undecylenicum .............................................................. 3176Acidum ursodeoxycholicum....................................................... 3180Acidum valproicum ...................................................................... 3190Acitretinum .....................................................................................1323Adapalenum ...................................................................................1324Adeninum........................................................................................1326Adenosinum ...................................................................................1327Adeps lanae ....................................................................................3228Adeps lanae cum aqua.................................................................3233Adeps lanae hydrogenatus .........................................................3232Adeps solidus.................................................................................. 2146Adrenalini tartras..........................................................................1330Adrenalinum ..................................................................................1329Aer medicinalis.............................................................................. 1331Aer medicinalis artificiosus .......................................................1333Aether ...............................................................................................1968Aether anaestheticus ....................................................................1968Aetherolea ......................................................................................... 673Agar ..................................................................................................1044Agni casti fructus ..........................................................................1044Agrimoniae herba .........................................................................1046Alaninum.........................................................................................1334Albendazolum ................................................................................1335Albumini humani solutio ............................................................ 2165Alchemillae herba .........................................................................1047Alcohol benzylicus ........................................................................1469Alcohol cetylicus............................................................................1647Alcohol cetylicus et stearylicus .................................................1643Alcohol cetylicus et stearylicus emulsificans A ....................1643Alcohol cetylicus et stearylicus emulsificans B ....................1645Alcoholes adipis lanae .................................................................3227Alcohol isopropylicus...................................................................2287Alcohol oleicus............................................................................... 2611Alcohol stearylicus........................................................................2991Alcuronii chloridum .....................................................................1336Alfacalcidolum ...............................................................................1337Alfadexum .......................................................................................1338Alfentanili hydrochloridum........................................................1339Alfuzosini hydrochloridum ........................................................ 1341Allantoinum....................................................................................1342Allii sativi bulbi pulvis ................................................................. 1133Allium sativum ad praeparationes homoeopathicas ...........1290Allopurinolum................................................................................1343Almagatum......................................................................................1345Aloe barbadensis ...........................................................................1047Aloe capensis..................................................................................1048Aloes extractum siccum normatum..........................................1049Alprazolamum ...............................................................................1347Alprenololi hydrochloridum.......................................................1349Alprostadilum.................................................................................1350Alteplasum ad iniectabile............................................................1352Althaeae folium.............................................................................. 1176Althaeae radix ................................................................................ 1177Altizidum .........................................................................................1356Alumen.............................................................................................1357Aluminii chloridum hexahydricum .........................................1357Aluminii hydroxidum hydricum ad adsorptionem ..............1357Aluminii magnesii silicas ...........................................................1358Aluminii natrii silicas .................................................................. 1361Aluminii oxidum hydricum ........................................................1359Aluminii phosphas hydricus ...................................................... 1361Aluminii phosphatis liquamen ..................................................1360Aluminii sulfas...............................................................................1362Alverini citras .................................................................................1363Amantadini hydrochloridum .....................................................1364Ambroxoli hydrochloridum ........................................................1365



Amfetamini sulfas .........................................................................1366Amikacini sulfas ............................................................................1369Amikacinum ...................................................................................1367Amiloridi hydrochloridum..........................................................1370Aminoglutethimidum ...................................................................1373Amiodaroni hydrochloridum .....................................................1375Amisulpridum ................................................................................1376Amitriptylini hydrochloridum ...................................................1377Amlodipini besilas ........................................................................1379Ammoniae (13N) solutio iniectabilis ........................................... 965Ammoniae solutio concentrata .................................................1380Ammonii bromidum .....................................................................1382Ammonii chloridum .....................................................................1383Ammonii glycyrrhizas .................................................................1384Ammonii hydrogenocarbonas ...................................................1385Ammonio methacrylatis copolymerum A............................... 1381Ammonio methacrylatis copolymerum B ..............................1382Amobarbitalum ..............................................................................1385Amobarbitalum natricum ...........................................................1386Amoxicillinum natricum.............................................................1386Amoxicillinum trihydricum........................................................1389Amphotericinum B ....................................................................... 1391Ampicillinum anhydricum .........................................................1393Ampicillinum natricum ...............................................................1395Ampicillinum trihydricum..........................................................1397Amygdalae oleum raffinatum ....................................................1346Amygdalae oleum virginale .......................................................1347Amyla hydroxyethyla ...................................................................2984Amylmetacresolum .......................................................................1399Amylum hydroxypropylum.........................................................2981Amylum pregelificatum ...............................................................2983Angelicae radix ..............................................................................1049Anisi aetheroleum.........................................................................1050Anisi fructus ...................................................................................1052Anisi stellati aetheroleum ...........................................................1245Anisi stellati fructus......................................................................1244Antazolini hydrochloridum ........................................................ 1401Anticorpora monoclonalia ad usum humanum ..................... 682Antithrombinum III humanum densatum ............................. 2168Apis mellifera ad praeparationes homoeopathicas..............1292Apomorphini hydrochloridum ..................................................1407Aprotinini solutio concentrata .................................................. 1411Aprotininum ...................................................................................1408Aqua ad dilutionem solutionum concentratarum adhaemodialysim ............................................................................ 2135

Aqua ad iniectabile ....................................................................... 3219Aquae (15O) solutio iniectabilis ..................................................1023Aquae tritiatae (3H) solutio iniectabilis ...................................1022Aqua purificata ..............................................................................3224Aqua valde purificata...................................................................3222Arachidis oleum hydrogenatum................................................ 1413Arachidis oleum raffinatum ....................................................... 1413Argenti nitras .................................................................................2905Argentum colloidale ad usum externum ................................2904Arginini aspartas .......................................................................... 1415Arginini hydrochloridum............................................................ 1415Argininum....................................................................................... 1414Argon ................................................................................................ 1416Arnicae flos.....................................................................................1053Arnicae tinctura ............................................................................1055Arsenii trioxidum ad praeparationes homoeopathicas ......1286Articaini hydrochloridum ........................................................... 1417Ascorbylis palmitas.......................................................................1420Asparaginum monohydricum.................................................... 1421Aspartamum ................................................................................... 1421Astragali mongholici radix .........................................................1060Atenololum......................................................................................1424Atracurii besilas.............................................................................1425Atropini sulfas................................................................................1429Atropinum .......................................................................................1427Aurantii amari epicarpii et mesocarpii tinctura ..................1078Aurantii amari epicarpium et mesocarpium.........................1077Aurantii amari flos .......................................................................1078

Aurantii dulcis aetheroleum.......................................................1249Auricularia........................................................................................ 709Azaperonum ad usum veterinarium........................................1430Azathioprinum............................................................................... 1431Azelastini hydrochloridum .........................................................1433Azithromycinum............................................................................1434

BBacampicillini hydrochloridum ................................................1439Bacitracinum..................................................................................1440Bacitracinum zincum ..................................................................1443Baclofenum.....................................................................................1445Ballotae nigrae herba ..................................................................1079Balsamum peruvianum............................................................... 1215Balsamum tolutanum ..................................................................1254Bambuteroli hydrochloridum ....................................................1446Barbitalum ......................................................................................1447Barii chloridum dihydricum ad praeparationeshomoeopathicas ..........................................................................1287

Barii sulfas ......................................................................................1448BCG ad immunocurationem ........................................................ 746Beclometasoni dipropionas anhydricus .................................1449Beclometasoni dipropionas monohydricus ........................... 1451Belladonnae folii extractum siccum normatum ...................1064Belladonnae folii tinctura normata .........................................1065Belladonnae folium ......................................................................1062Belladonnae pulvis normatus....................................................1066Benazeprili hydrochloridum .....................................................1454Bendroflumethiazidum ...............................................................1456Benfluorexi hydrochloridum .....................................................1457Benperidolum ................................................................................1458Benserazidi hydrochloridum .....................................................1459Bentonitum .....................................................................................1460Benzalkonii chloridi solutio ......................................................1463Benzalkonii chloridum................................................................ 1461Benzbromaronum .........................................................................1465Benzethonii chloridum ...............................................................1466Benzocainum .................................................................................1466Benzoe sumatranus......................................................................1068Benzoe tonkinensis ......................................................................1067Benzois sumatrani tinctura........................................................1069Benzois tonkinensis tinctura .....................................................1069Benzoylis peroxidum cum aqua ...............................................1468Benzylis benzoas...........................................................................1470Benzylpenicillinum benzathinum............................................ 1471Benzylpenicillinum kalicum......................................................1473Benzylpenicillinum natricum ................................................... 1476Benzylpenicillinum procainum ................................................ 1474Betacarotenum ..............................................................................1477Betadexum ......................................................................................1478Betahistini dihydrochloridum ...................................................1479Betahistini mesilas .......................................................................1480Betamethasoni acetas ..................................................................1483Betamethasoni dipropionas .......................................................1485Betamethasoni natrii phosphas ................................................1486Betamethasoni valeras.................................................................1488Betamethasonum .......................................................................... 1481Betaxololi hydrochloridum.........................................................1489Betulae folium................................................................................ 1071Bezafibratum ..................................................................................1490Bifonazolum ................................................................................... 1491Biotinum .........................................................................................1492Biperideni hydrochloridum .......................................................1493Bisacodylum ...................................................................................1495Bismuthi subcarbonas .................................................................1496Bismuthi subgallas .......................................................................1497Bismuthi subnitras ponderosus.................................................1498Bismuthi subsalicylas ..................................................................1498Bisoprololi fumaras ......................................................................1499Bistortae rhizoma .........................................................................1072Bleomycini sulfas ..........................................................................1502Boldi folii extractum siccum ......................................................1083



Boldi folium .................................................................................... 1081Boragonis officinalis oleum raffinatum..................................1503Borax ................................................................................................1503Bromazepamum ............................................................................1507Bromhexini hydrochloridum .....................................................1508Bromocriptini mesilas .................................................................1509Bromperidoli decanoas ............................................................... 1512Bromperidolum ............................................................................. 1511Brompheniramini maleas .......................................................... 1514Brotizolamum ................................................................................ 1515Budesonidum ................................................................................. 1516Bufexamacum ................................................................................ 1518Buflomedili hydrochloridum ..................................................... 1519Bumetanidum ................................................................................1520Bupivacaini hydrochloridum..................................................... 1521Buprenorphini hydrochloridum ...............................................1524Buprenorphinum ..........................................................................1523Buserelinum ...................................................................................1526Buspironi hydrochloridum.........................................................1527Busulfanum ....................................................................................1529Butylhydroxyanisolum ................................................................ 1531Butylhydroxytoluenum................................................................ 1531Butylis parahydroxybenzoas......................................................1530

CCabergolinum ................................................................................1535Cadmii sulfas hydricusad praeparationes homoeopathicas.......................................1287

Calcifediolum .................................................................................1538Calcii acetas anhydricus .............................................................1547Calcii ascorbas ...............................................................................1548Calcii carbonas ..............................................................................1549Calcii chloridum dihydricum ....................................................1550Calcii chloridum hexahydricum ...............................................1550Calcii dobesilas monohydricus ................................................. 1551Calcii folinas ..................................................................................1552Calcii glucoheptonas....................................................................1554Calcii gluconas ..............................................................................1555Calcii gluconas ad iniectabile ...................................................1556Calcii gluconas anhydricus........................................................1555Calcii glycerophosphas................................................................1557Calcii hydrogenophosphas anhydricus...................................1558Calcii hydrogenophosphas dihydricus....................................1559Calcii hydroxidum ........................................................................1560Calcii iodidum tetrahydricum ad praeparationeshomoeopathicas ..........................................................................1288

Calcii lactas anhydricus .............................................................. 1561Calcii lactas monohydricus ........................................................ 1561Calcii lactas pentahydricus ........................................................1562Calcii lactas trihydricus ..............................................................1562Calcii laevulinas dihydricus.......................................................1565Calcii levofolinas pentahydricus ..............................................1563Calcii pantothenas ........................................................................1566Calcii stearas ..................................................................................1567Calcii sulfas dihydricus ...............................................................1569Calcipotriolum anhydricum.......................................................1539Calcipotriolum monohydricum.................................................1542Calcitoninum salmonis ...............................................................1544Calcitriolum....................................................................................1546Calendulae flos ..............................................................................1086Camphora racemica .....................................................................1571Capsici fructus ...............................................................................1087Capsici oleoresina raffinata et quantificata ..........................1089Capsici tinctura normata ............................................................1090Capsulae ............................................................................................ 707Captoprilum ...................................................................................1573Carbacholum ..................................................................................1575Carbamazepinum .........................................................................1576Carbasalatum calcicum ...............................................................1577Carbidopum ....................................................................................1579Carbimazolum ...............................................................................1580Carbo activatus ..............................................................................1649

Carbocisteinum ............................................................................. 1581Carbomera ...................................................................................... 1581Carbonei dioxidum .......................................................................1583Carbonei monoxidum ..................................................................1584Carbonei monoxidum (15O) .......................................................... 965Carboplatinum...............................................................................1585Carboprostum trometamolum ...................................................1586Carboxymethylamylum natricum A.........................................2944Carboxymethylamylum natricum B.........................................2945Carboxymethylamylum natricum C.........................................2946Carisoprodolum.............................................................................1587Carmellosum ..................................................................................1588Carmellosum calcicum ................................................................1589Carmellosum natricum ...............................................................1589Carmellosum natricum conexum .............................................1770Carmellosum natricum substitutum humile..........................1590Carmustinum ................................................................................. 1591Carprofenum ad usum veterinarium.......................................1592Carrageenanum.............................................................................1593Carteololi hydrochloridum .........................................................1594Carthami flos .................................................................................1229Carthami oleum raffinatum .......................................................2879Carvedilolum ..................................................................................1595Carvi aetheroleum ........................................................................ 1091Carvi fructus...................................................................................1090Caryophylli floris aetheroleum ................................................. 1106Caryophylli flos ............................................................................. 1105Cefaclorum .....................................................................................1599Cefadroxilum monohydricum ...................................................1600Cefalexinum monohydricum .....................................................1602Cefalotinum natricum .................................................................1603Cefamandoli nafas ........................................................................1605Cefapirinum natricum.................................................................1606Cefatrizinum propylen glycolum..............................................1607Cefazolinum natricum.................................................................1608Cefepimi dihydrochloridum monohydricum......................... 1610Cefiximum....................................................................................... 1612Cefoperazonum natricum........................................................... 1613Cefotaximum natricum ............................................................... 1615Cefoxitinum natricum ................................................................. 1617Cefpodoximum proxetili.............................................................. 1618Cefradinum .....................................................................................1620Ceftazidimum pentahydricum ..................................................1622Ceftazidimum pentahydricum et natrii carbonas adiniectabile .....................................................................................1624

Ceftriaxonum natricum...............................................................1626Cefuroximum axetili.....................................................................1627Cefuroximum natricum...............................................................1629Celiprololi hydrochloridum........................................................1630Cellulae stirpes haematopoieticae humanae......................... 2175Cellulosi acetas .............................................................................. 1631Cellulosi acetas butyras ...............................................................1632Cellulosi acetas phthalas.............................................................1633Cellulosi pulvis ..............................................................................1638Cellulosum microcristallinum ...................................................1634Cellulosum microcristallinum et carmellosum natricum ..2507Centaurii herba .............................................................................1095Centellae asiaticae herba ............................................................1096Cera alba .........................................................................................1453Cera carnauba ...............................................................................1592Cera flava ........................................................................................1454Cetirizini dihydrochloridum ...................................................... 1641Cetobemidoni hydrochloridum ................................................. 2316Cetostearylis isononanoas..........................................................1646Cetrimidum.....................................................................................1646Cetylis palmitas .............................................................................1648Cetylpyridinii chloridum ............................................................1648Chamomillae romanae flos ........................................................1098Chelidonii herba............................................................................ 1145Chinidini sulfas .............................................................................2833Chinini hydrochloridum .............................................................2834Chinini sulfas .................................................................................2835Chitosani hydrochloridum ......................................................... 1651



Chlorali hydras ..............................................................................1652Chlorambucilum............................................................................1653Chloramphenicoli natrii succinas ............................................1655Chloramphenicoli palmitas ........................................................1654Chloramphenicolum.....................................................................1653Chlorcyclizini hydrochloridum .................................................1656Chlordiazepoxidi hydrochloridum ...........................................1658Chlordiazepoxidum ......................................................................1657Chlorhexidini diacetas.................................................................1659Chlorhexidini digluconatis solutio...........................................1660Chlorhexidini dihydrochloridum..............................................1662Chlorobutanolum anhydricum..................................................1663Chlorobutanolum hemihydricum .............................................1663Chlorocresolum .............................................................................1664Chloroquini phosphas .................................................................1665Chloroquini sulfas.........................................................................1665Chlorothiazidum ...........................................................................1666Chlorphenamini maleas..............................................................1667Chlorpromazini hydrochloridum .............................................1668Chlorpropamidum ........................................................................1669Chlorprothixeni hydrochloridum .............................................1670Chlortalidonum .............................................................................1671Chlortetracyclini hydrochloridum............................................1673Cholecalciferoli pulvis .................................................................1677Cholecalciferolum ......................................................................... 1674Cholecalciferolum densatum oleosum ....................................1675Cholecalciferolum in aqua dispergibile ..................................1678Cholesterolum ................................................................................1680Chondroitini natrii sulfas ........................................................... 1681Chorda resorbilis sterilis .............................................................1027Chorda resorbilis sterilis in fuso ad usum veterinarium ...1037Chromii (51Cr) edetatis solutio iniectabilis ............................... 966Chymotrypsinum ..........................................................................1683Ciclopirox olaminum ...................................................................1686Ciclopiroxum..................................................................................1684Ciclosporinum ...............................................................................1687Cilastatinum natricum ................................................................1688Cilazaprilum ..................................................................................1690Cimetidini hydrochloridum .......................................................1693Cimetidinum .................................................................................. 1691Cinchocaini hydrochloridum ....................................................1694Cinchonae cortex ..........................................................................1098Cinchonae extractum fluidum normatum ............................. 1100Cineolum .........................................................................................1695Cinnamomi cassiae aetheroleum .............................................1095Cinnamomi cortex ........................................................................ 1101Cinnamomi corticis tinctura...................................................... 1103Cinnamomi zeylanici folii aetheroleum ................................. 1102Cinnamomi zeylanicii corticis aetheroleum ......................... 1101Cinnarizinum ................................................................................1696Ciprofibratum.................................................................................1697Ciprofloxacini hydrochloridum ................................................1700Ciprofloxacinum ...........................................................................1698Cisplatinum .................................................................................... 1701Citaloprami hydrobromidum .....................................................1703Citaloprami hydrochloridum .....................................................1704Citri reticulatae aetheroleum..................................................... 1175Citronellae aetheroleum.............................................................. 1103Cladribinum ...................................................................................1707Clarithromycinum ........................................................................1708Clazurilum ad usum veterinarium........................................... 1710Clebopridi malas ........................................................................... 1712Clemastini fumaras ...................................................................... 1713Clenbuteroli hydrochloridum .................................................... 1715Clindamycini hydrochloridum .................................................. 1716Clindamycini phosphas............................................................... 1717Clioquinolum ................................................................................. 1718Clobazamum .................................................................................. 1719Clobetasoli propionas ..................................................................1720Clobetasoni butyras ......................................................................1722Clofaziminum ................................................................................1724Clofibratum .....................................................................................1725Clomifeni citras .............................................................................1726

Clomipramini hydrochloridum .................................................1727Clonazepamum .............................................................................1729Clonidini hydrochloridum..........................................................1730Clopamidum ................................................................................... 1731Closantelum natricum dihydricumad usum veterinarium ...............................................................1732

Clotrimazolum ...............................................................................1734Cloxacillinum natricum ..............................................................1735Clozapinum ....................................................................................1737Cocaini hydrochloridum .............................................................1738Cocois oleum raffinatum ............................................................1739Cocoylis caprylocapras................................................................ 1740Codeini hydrochloridum dihydricum...................................... 1742Codeini phosphas hemihydricus .............................................. 1743Codeini phosphas sesquihydricus ............................................ 1745Codeinum ........................................................................................ 1740Codergocrini mesilas ................................................................... 1747Coffeinum........................................................................................1536Coffeinum monohydricum .........................................................1537Colae semen ................................................................................... 1107Colchicinum ...................................................................................1759Colestyraminum ............................................................................ 1761Colistimethatum natricum ......................................................... 1762Colistini sulfas ............................................................................... 1763Colophonium ................................................................................. 1107Compressi.......................................................................................... 736Copolymerum macrogolo et alcoholi poly(vinylico)constatum .....................................................................................2401

Copolymerum methacrylatis butylati basicum .....................1448Copovidonum................................................................................. 1764Coriandri aetheroleum ................................................................ 1108Coriandri fructus .......................................................................... 1108Corpora ad usum pharmaceuticum ........................................... 694Cortisoni acetas ............................................................................. 1767Crataegi folii cum floreextractum fluidum quantificatum .......................................... 1150

Crataegi folii cum flore extractum siccum ............................. 1149Crataegi folium cum flore........................................................... 1148Crataegi fructus ............................................................................. 1147Cresolum crudum .........................................................................1770Croci stigma ad praeparationes homoeopathicas ................1296Crospovidonum ............................................................................. 1771Crotamitonum................................................................................1773Cupri acetas monohydricus ad praeparationeshomoeopathicas ..........................................................................1289

Cupri sulfas anhydricus .............................................................. 1766Cupri sulfas pentahydricus ........................................................ 1766Cuprum ad praeparationes homoeopathicas ........................1289Curcumae xanthorrhizae rhizoma...........................................1257Cyamopsidis seminis pulvis ....................................................... 1146Cyanocobalamini (57Co) capsulae .............................................. 967Cyanocobalamini (57Co) solutio .................................................. 968Cyanocobalamini (58Co) capsulae .............................................. 968Cyanocobalamini (58Co) solutio .................................................. 969Cyanocobalaminum ..................................................................... 1774Cyclizini hydrochloridum...........................................................1775Cyclopentolati hydrochloridum ................................................ 1776Cyclophosphamidum ...................................................................1777Cynarae folii extractum siccum ................................................1058Cynarae folium ..............................................................................1056Cyproheptadini hydrochloridum ..............................................1778Cyproteroni acetas........................................................................1779Cysteini hydrochloridum monohydricum.............................. 1781Cystinum .........................................................................................1782Cytarabinum...................................................................................1783

DDacarbazinum ...............................................................................1787Dalteparinum natricum ..............................................................1788Danaparoidum natricum ............................................................1789Dapsonum .......................................................................................1792Daunorubicini hydrochloridum................................................1792



D-Camphora ....................................................................................1569Decylis oleas ...................................................................................1794Deferoxamini mesilas ..................................................................1794Dembrexini hydrochloridum monohydricum ad usumveterinarium ................................................................................1795

Demeclocyclini hydrochloridum ..............................................1796Deptropini citras ...........................................................................1797Dequalinii chloridum...................................................................1798Desfluranum...................................................................................1800Desipramini hydrochloridum .................................................... 1801Deslanosidum ................................................................................1802Desmopressinum...........................................................................1803Desogestrelum................................................................................1804Desoxycortoni acetas ...................................................................1805Detomidini hydrochloridum ad usum veterinarium ...........1806Dexamethasoni acetas .................................................................1809Dexamethasoni isonicotinas ...................................................... 1811Dexamethasoni natrii phosphas ............................................... 1812Dexamethasonum .........................................................................1807Dexchlorpheniramini maleas .................................................... 1814Dexpanthenolum........................................................................... 1815Dextranomerum ............................................................................ 1819Dextranum 1 ad iniectabile ....................................................... 1816Dextranum 40 ad iniectabile ..................................................... 1817Dextranum 60 ad iniectabile ..................................................... 1818Dextranum 70 ad iniectabile ..................................................... 1819Dextrinum .......................................................................................1820Dextromethorphani hydrobromidum ...................................... 1821Dextromoramidi tartras...............................................................1822Dextropropoxypheni hydrochloridum.....................................1823Diazepamum ..................................................................................1824Diazoxidum ....................................................................................1825Dibrompropamidini diisetionas................................................1826Dibutylis phthalas .........................................................................1827Diclazurilum ad usum veterinarium .......................................1828Diclofenacum kalicum.................................................................1829Diclofenacum natricum ..............................................................1830Dicloxacillinum natricum........................................................... 1831Dicycloverini hydrochloridum ..................................................1833Didanosinum..................................................................................1833Dienestrolum ..................................................................................1835Diethylcarbamazini citras ..........................................................1836Diethylenglycoli aether monoethilicus ...................................1837Diethylenglycoli palmitostearas................................................1839Diethylis phthalas .........................................................................1835Diethylstilbestrolum .....................................................................1839Diflunisalum ..................................................................................1840Digitalis purpureae folium ......................................................... 1114Digitoxinum.................................................................................... 1841Digoxinum ......................................................................................1842Dihydralazini sulfas hydricus....................................................1844Dihydrocodeini hydrogenotartras ............................................1845Dihydroergocristini mesilas .......................................................1846Dihydroergotamini mesilas ........................................................1849Dihydroergotamini tartras..........................................................1850Dihydrostreptomycini sulfas ad usum veterinarium........... 1851Dihydrotachysterolum .................................................................1853Dikalii clorazepas .........................................................................1869Dikalii phosphas............................................................................1870Diltiazemi hydrochloridum ........................................................1855Dimenhydrinatum ........................................................................1856Dimercaprolum..............................................................................1858Dimethylacetamidum...................................................................1859Dimethylis sulfoxidum .................................................................1858Dimeticonum..................................................................................1860Dimetindeni maleas .....................................................................1860Dinatrii clodronas tetrahydricus ..............................................1723Dinatrii edetas ............................................................................... 1874Dinatrii etidronas .........................................................................1979Dinatrii pamidronas pentahydricus ........................................2660Dinatrii phosphas anhydricus...................................................1875Dinatrii phosphas dihydricus ....................................................1875Dinatrii phosphas dodecahydricus .......................................... 1876

Dinitrogenii oxidum.....................................................................2585Dinoprostonum..............................................................................1863Dinoprostum trometamolum .....................................................1862Diosminum .....................................................................................1864Diphenhydramini hydrochloridum ..........................................1866Diphenoxylati hydrochloridum .................................................1867Dipivefrini hydrochloridum .......................................................1867Diprophyllinum .............................................................................1870Dipyridamolum .............................................................................1871Dirithromycinum ..........................................................................1872Disopyramidi phosphas...............................................................1877Disopyramidum ............................................................................. 1876Disulfiramum .................................................................................1878Dithranolum ...................................................................................1879DL-Methioninum ............................................................................2466DL-α-Tocopherylis hydrogenosuccinas.................................... 3110Dobutamini hydrochloridum .....................................................1880Docetaxelum trihydricum ........................................................... 1881Dodecylis gallas .............................................................................1884Domperidoni maleas ....................................................................1886Domperidonum .............................................................................1885Dopamini hydrochloridum.........................................................1887Dopexamini dihydrochloridum.................................................1889Dorzolamidi hydrochloridum ....................................................1890Dosulepini hydrochloridum .......................................................1892Doxaprami hydrochloridum ......................................................1893Doxazosini mesilas.......................................................................1894Doxepini hydrochloridum ..........................................................1895Doxorubicini hydrochloridum...................................................1897Doxycyclini hyclas........................................................................1898Doxycyclinum monohydricum ..................................................1899Doxylamini hydrogenosuccinas ............................................... 1901Droperidolum.................................................................................1902Drospirenonum .............................................................................1903Dydrogesteronum .........................................................................1905

EEbastinum .......................................................................................1909Echinaceae angustifoliae radix................................................. 1193Echinaceae pallidae radix ..........................................................1208Echinaceae purpureae herba..................................................... 1218Echinaceae purpureae radix...................................................... 1219Econazoli nitras ............................................................................ 1911Econazolum.................................................................................... 1910Edrophonii chloridum ................................................................. 1913Eleutherococci radix .................................................................... 1118Emedastini difumaras.................................................................. 1913Emetini hydrochloridum heptahydricum............................... 1914Emetini hydrochloridum pentahydricum .............................. 1915Emplastra transcutanea ................................................................ 726Enalaprilatum dihydricum......................................................... 1918Enalaprili maleas.......................................................................... 1916Enilconazolum ad usum veterinarium ................................... 1919Enoxaparinum natricum ............................................................1920Enoxolonum ................................................................................... 1921Enrofloxacinum ad usum veterinarium .................................1922Entacaponum.................................................................................1924Ephedrae herba ............................................................................1120Ephedrini hydrochloridum ........................................................1927Ephedrini racemici hydrochloridum .......................................1928Ephedrinum anhydricum ...........................................................1925Ephedrinum hemihydricum ......................................................1926Epinastini hydrochloridum ........................................................1928Epirubicini hydrochloridum ......................................................1929Equiseti herba ................................................................................ 1121Ergocalciferolum ........................................................................... 1931Ergometrini maleas ......................................................................1933Ergotamini tartras ........................................................................1934Erythritolum...................................................................................1935Erythromycini estolas..................................................................1938Erythromycini ethylsuccinas .....................................................1940Erythromycini lactobionas .........................................................1942



Erythromycini stearas .................................................................1944Erythromycinum ...........................................................................1936Erythropoietini solutio concentrata.........................................1946Eserini salicylas ............................................................................2726Eserini sulfas..................................................................................2727Esketamini hydrochloridum ......................................................1950Esomeprazolum magnesicum trihydricum ........................... 1951Estradioli benzoas.........................................................................1953Estradioli valeras...........................................................................1955Estradiolum hemihydricum .......................................................1954Estriolum .........................................................................................1956Estrogeni coniuncti ......................................................................1958Etamsylatum .................................................................................. 1961Ethacridini lactas monohydricus .............................................1962Ethambutoli hydrochloridum ....................................................1963Ethanolum (96 per centum) .......................................................1964Ethanolum anhydricum ..............................................................1966Ethinylestradiolum .......................................................................1969Ethionamidum ...............................................................................1970Ethosuximidum .............................................................................1971Ethylcellulosum .............................................................................1975Ethylendiaminum .........................................................................1977Ethylenglycoli monopalmitostearas......................................... 1976Ethylis acetas .................................................................................1972Ethylis oleas....................................................................................1973Ethylis parahydroxybenzoas......................................................1973Ethylis parahydroxybenzoas natricus ..................................... 1974Ethylmorphini hydrochloridum ................................................1978Etilefrini hydrochloridum...........................................................1979Etodolacum ..................................................................................... 1981Etofenamatum ...............................................................................1982Etofyllinum .....................................................................................1984Etomidatum ....................................................................................1985Etoposidum.....................................................................................1986Eucalypti aetheroleum ................................................................1123Eucalypti folium ............................................................................1122Eugenolum......................................................................................1990Extracta.............................................................................................. 674

FFactor humanus von Willebrandi ............................................. 2189Factor IX coagulationis humanus ............................................ 2172Factor VII coagulationis humanus .......................................... 2169Factor VIII coagulationis humanus......................................... 2170Factor VIII coagulationis humanus (ADNr) .......................... 2171Factor XI coagulationis humanus ............................................ 2173Fagopyri herba ..............................................................................1084Famotidinum..................................................................................1995Febantelum ad usum veterinarium..........................................1996Felbinacum .....................................................................................1997Felodipinum ...................................................................................1998Felypressinum................................................................................1999Fenbendazolum ad usum veterinarium..................................2000Fenbufenum....................................................................................2001Fenofibratum..................................................................................2002Fenoteroli hydrobromidum ........................................................2003Fentanyli citras ..............................................................................2006Fentanylum.....................................................................................2005Fenticonazoli nitras .....................................................................2007Ferri chloridum hexahydricum.................................................2008Ferrosi fumaras .............................................................................2009Ferrosi gluconas ............................................................................ 2010Ferrosi sulfas desiccatus ............................................................. 2011Ferrosi sulfas heptahydricus ...................................................... 2012Ferrum ad praeparationes homoeopathicas .........................1294Fexofenadini hydrochloridum ................................................... 2013Fibrini glutinum............................................................................ 2014Fibrinogenum humanum ........................................................... 2174Fila non resorbilia sterilia ..........................................................1028Fila non resorbilia sterilia in fuso ad usum veterinarium ..1039Fila resorbilia synthetica monofilamenta sterilia ................1033Fila resorbilia synthetica torta sterilia .................................... 1031

Filgrastimi solutio concentrata ................................................. 2015Filipendulae ulmariae herba ..................................................... 1182Filum bombycis tortum sterile in fuso ad usumveterinarium ................................................................................1039

Filum ethyleni polyterephthalici sterile in fuso ad usumveterinarium ................................................................................1039

Filum lini sterile in fuso ad usum veterinarium ..................1038Filum polyamidicum-6/6 sterile in fuso ad usumveterinarium ................................................................................1038

Filum polyamidicum-6 sterile in fuso ad usumveterinarium ................................................................................1038

Finasteridum .................................................................................. 2018Flavoxati hydrochloridum ..........................................................2021Flecainidi acetas ...........................................................................2022Flubendazolum ..............................................................................2024Flucloxacillinum magnesicum octahydricum.......................2025Flucloxacillinum natricum.........................................................2026Fluconazolum ................................................................................2028Flucytosinum .................................................................................2029Fludarabini phosphas ..................................................................2031Fludeoxyglucosi (18F) solutio iniectabilis ................................. 969Fludrocortisoni acetas .................................................................2033Flumazenili (N-[11C]methyl) solutio iniectabilis ..................... 972Flumazenilum................................................................................2035Flumequinum.................................................................................2036Flumetasoni pivalas .....................................................................2037Flunarizini dihydrochloridum ..................................................2038Flunitrazepamum .........................................................................2039Flunixini megluminum ad usum veterinarium....................2040Fluocinoloni acetonidum ...........................................................2041Fluocortoloni pivalas ...................................................................2042Fluoresceinum ...............................................................................2044Fluoresceinum natricum ............................................................2045Fluoridi (18F) solutio ad radio-signandum ............................... 973Fluorodopae (18F) ab electrophila substitutione solutioiniectabilis ...................................................................................... 974

Fluorouracilum..............................................................................2046Fluoxetini hydrochloridum ........................................................2048Flupentixoli dihydrochloridum .................................................2049Fluphenazini decanoas ...............................................................2051Fluphenazini dihydrochloridum ..............................................2052Fluphenazini enantas..................................................................2054Flurazepami monohydrochloridum.........................................2055Flurbiprofenum .............................................................................2056Fluspirilenum ................................................................................2057Flutamidum ....................................................................................2058Fluticasoni propionas ..................................................................2059Flutrimazolum ...............................................................................2061Fluvastatinum natricum .............................................................2062Fluvoxamini maleas .....................................................................2063Foeniculi amari fructus...............................................................1124Foeniculi amari fructus aetheroleum......................................1073Foeniculi amari herbae aetheroleum ......................................1075Foeniculi dulcis fructus...............................................................1125Formaldehydi solutio (35 per centum)....................................2066Formoteroli fumaras dihydricus ...............................................2067Foscarnetum natricum hexahydricum....................................2069Fosfomycinum calcicum .............................................................2070Fosfomycinum natricum.............................................................2071Fosfomycinum trometamolum ..................................................2072Fosinoprilum natricum ...............................................................2073Framycetini sulfas ........................................................................2076Frangulae cortex ...........................................................................1128Frangulae corticis extractum siccum normatum .................1129Fraxini folium ................................................................................1059Fructosum .......................................................................................2077Fucus vel Ascophyllum ................................................................ 1161Fumariae herba ............................................................................. 1132Furosemidum .................................................................................2078

GGalactosum .....................................................................................2083



Galantamini hydrobromidum....................................................2083Gallii (67Ga) citratis solutio iniectabilis ..................................... 975Ganciclovirum ...............................................................................2086Gelatina ...........................................................................................2087Gemcitabini hydrochloridum.....................................................2088Gemfibrozilum ...............................................................................2090Gentamicini sulfas ........................................................................2091Gentianae radix ............................................................................. 1133Gentianae tinctura........................................................................ 1134Gestodenum ....................................................................................2092Ginkgonis extractum siccum raffinatumet quantificatum .. 1136Ginkgonis folium........................................................................... 1138Ginseng radix ................................................................................. 1140Glibenclamidum ............................................................................2094Gliclazidum.....................................................................................2096Glimepiridum .................................................................................2097Glipizidum ......................................................................................2098Glossa ................................................................................................. 707Glucagonum humanum .............................................................. 2100Glucosum anhydricum ................................................................ 2102Glucosum liquidum ...................................................................... 2103Glucosum liquidum dispersione desiccatum......................... 2103Glucosum monohydricum .......................................................... 2104Glutathionum ................................................................................. 2106Glyceroli dibehenas ...................................................................... 2110Glyceroli distearas ........................................................................ 2111Glyceroli monocaprylas .............................................................. 2112Glyceroli monocaprylocapras.................................................... 2113Glyceroli monolinoleas .............................................................. 2114Glyceroli mono-oleas.................................................................... 2115Glyceroli monostearas 40-55...................................................... 2116Glyceroli trinitratis solutio ......................................................... 2117Glycerolum...................................................................................... 2108Glycerolum (85 per centum) ...................................................... 2109Glycinum ......................................................................................... 2118Gonadorelini acetas ..................................................................... 2119Gonadotropinum chorionicum .................................................2120Gonadotropinum sericum equinum ad usumveterinarium ................................................................................ 2121

Goserelinum ................................................................................... 2121Gossypii oleum hydrogenatum.................................................. 1769Gramicidinum ................................................................................2123Graminis rhizoma......................................................................... 1109Granisetroni hydrochloridum....................................................2124Granulata .......................................................................................... 713Griseofulvinum ..............................................................................2126Guaiacolum ....................................................................................2127Guaifenesinum ..............................................................................2128Guanethidini monosulfas ...........................................................2129Guar galactomannanum ............................................................. 2130

HHalofantrini hydrochloridum .................................................... 2141Haloperidoli decanoas................................................................. 2143Haloperidolum ............................................................................... 2142Halothanum.................................................................................... 2144Hamamelidis folium ..................................................................... 1146Harpagophyti extractum siccum............................................... 1112Harpagophyti radix ...................................................................... 1113Hederae folium .............................................................................. 1157Hedera helix ad praeparationes homoeopathicas................ 1291Helianthi annui oleum raffinatum...........................................3028Helium ............................................................................................. 2146Heparina massae molecularis minoris ................................... 2151Heparinum calcicum ................................................................... 2147Heparinum natricum ................................................................... 2149Heptaminoli hydrochloridum .................................................... 2153Hexamidini diisetionas ............................................................... 2154Hexetidinum ................................................................................... 2155Hexobarbitalum ............................................................................. 2156Hexylresorcinolum ....................................................................... 2157Hibisci sabdariffae flos ................................................................1226

Histamini dihydrochloridum ..................................................... 2158Histamini phosphas...................................................................... 2159Histidini hydrochloridum monohydricum............................. 2160Histidinum ...................................................................................... 2159Homatropini hydrobromidum ................................................... 2161Homatropini methylbromidum ................................................. 2162Hyaluronidasum ........................................................................... 2190Hydralazini hydrochloridum ..................................................... 2191Hydrargyri dichloridum ..............................................................2449Hydrastis rhizoma ........................................................................ 1143Hydrochlorothiazidum ................................................................ 2193Hydrocodoni hydrogenotartras 2.5-hydricus ........................ 2194Hydrocortisoni acetas .................................................................. 2198Hydrocortisoni hydrogenosuccinas .........................................2200Hydrocortisonum .......................................................................... 2196Hydrogenii peroxidum 30 per centum....................................2202Hydrogenii peroxidum 3 per centum ......................................2201Hydromorphoni hydrochloridum .............................................2202Hydroxocobalamini acetas .........................................................2203Hydroxocobalamini chloridum .................................................2204Hydroxocobalamini sulfas ..........................................................2205Hydroxycarbamidum ...................................................................2206Hydroxyethylcellulosum..............................................................2208Hydroxyethylis salicylas..............................................................2207Hydroxypropylbetadexum .......................................................... 2210Hydroxypropylcellulosum .......................................................... 2211Hydroxyzini hydrochloridum ....................................................2212Hymecromonum............................................................................ 2213Hyoscini butylbromidum ............................................................ 2215Hyoscini hydrobromidum........................................................... 2216Hyoscinum ...................................................................................... 2214Hyoscyamini sulfas ...................................................................... 2217Hyoscyamus niger ad praeparationes homoeopathicas.....1292Hyperici herba ...............................................................................1241Hyperici herbae extractum siccum quantificatum...............1242Hypericum perforatumad praeparationes homoeopathicas.......................................1293

Hypromellosi phthalas.................................................................2221Hypromellosum ............................................................................. 2219

IIbuprofenum...................................................................................2225Ichthammolum ..............................................................................2227Idoxuridinum .................................................................................2227Iecoris aselli oleum A...................................................................1752Iecoris aselli oleum B ..................................................................1756Iecoris aselli oleum domestici ................................................... 1748Ifosfamidum ...................................................................................2228Imipenemum ..................................................................................2230Imipramini hydrochloridum......................................................2231Immunoglobulinum anti-T lymphocytorum ex animale adusum humanum ..........................................................................1404

Immunoglobulinum humanum anti-D.................................... 2166Immunoglobulinum humanum anti-D ad usumintravenosum ............................................................................... 2167

Immunoglobulinum humanum hepatitidis A ....................... 2176Immunoglobulinum humanum hepatitidis B ....................... 2176Immunoglobulinum humanum hepatitidis B ad usumintravenosum ............................................................................... 2176

Immunoglobulinum humanum morbillicum ........................ 2177Immunoglobulinum humanum normale ............................... 2177Immunoglobulinum humanum normale ad usumintravenosum ............................................................................... 2179

Immunoglobulinum humanum rabicum................................ 2186Immunoglobulinum humanum rubellae ................................ 2187Immunoglobulinum humanum tetanicum ............................ 2187Immunoglobulinum humanum varicellae ............................. 2188Immunoglobulinum humanum varicellae ad usumintravenosum ............................................................................... 2189

Immunosera ad usum veterinarium .......................................... 680Immunosera ex animale ad usum humanum ......................... 678Immunoserum botulinicum ......................................................... 949



Immunoserum Clostridii novyi alpha ad usumveterinarium .................................................................................. 957

Immunoserum Clostridii perfringentis beta ad usumveterinarium .................................................................................. 958

Immunoserum Clostridii perfringentis epsilon ad usumveterinarium .................................................................................. 959

Immunoserum contra venena viperarum europaearum ..... 953Immunoserum diphthericum ...................................................... 949Immunoserum gangraenicum (Clostridium novyi) .............. 950Immunoserum gangraenicum (Clostridium perfringens) ... 951Immunoserum gangraenicum (Clostridium septicum) ........ 952Immunoserum gangraenicum mixtum ..................................... 950Immunoserum tetanicum ad usum humanum....................... 953Immunoserum tetanicum ad usum veterinarium.................. 960Indapamidum ................................................................................2232Indii (111In) chloridi solutio .......................................................... 977Indii (111In) oxini solutio ............................................................... 978Indii (111In) pentetatis solutio iniectabilis ................................ 979Indinaviri sulfas ............................................................................2233Indometacinum .............................................................................2235Inhalanda.......................................................................................... 728Insulini zinci amorphi suspensio iniectabilis.......................2252Insulini zinci cristallini suspensio iniectabilis.....................2252Insulini zinci suspensio iniectabilis ........................................2251Insulinum aspartum ....................................................................2237Insulinum biphasicum iniectabile ...........................................2243Insulinum bovinum......................................................................2239Insulinum humanum...................................................................2241Insulinum isophanum biphasicum iniectabile .....................2244Insulinum isophanum iniectabile ............................................2244Insulinum lisprum........................................................................2245Insulinum porcinum ....................................................................2247Insulinum solubile iniectabile ...................................................2244Interferoni alfa-2 solutio concentrata......................................2252Interferoni beta-1a solutio concentrata...................................2255Interferoni gamma-1b solutio concentrata ............................2257int-rac-α-Tocopherolum ............................................................... 3104int-rac-α-Tocopherylis acetas ..................................................... 3106Iobenguani (123I) solutio iniectabilis .......................................... 979Iobenguani (131I) solutio iniectabilis ad usumdiagnosticum ................................................................................. 980

Iobenguani (131I) solutio iniectabilis ad usumtherapeuticum................................................................................ 981

Iobenguani sulfas ad radiopharmaceutica .............................. 982Iodinati (125I) humani albumini solutio iniectabilis .............. 976Iodixanolum ...................................................................................2261Iodomethylnorcholesteroli (131I) solutio iniectabilis .............. 982Iodum ...............................................................................................2261Iohexolum .......................................................................................2264Iopamidolum ..................................................................................2266Iopromidum....................................................................................2269Iotrolanum ......................................................................................2273Ipecacuanhae extractum fluidum normatum ....................... 1153Ipecacuanhae pulvis normatus ................................................. 1154Ipecacuanhae radix ...................................................................... 1155Ipecacuanhae tinctura normata ............................................... 1156Ipratropii bromidum ....................................................................2277Irbesartanum..................................................................................2278Isoconazoli nitras .........................................................................2281Isoconazolum.................................................................................2279Isofluranum ....................................................................................2282Isoleucinum ....................................................................................2283Isomaltum .......................................................................................2284Isoniazidum ...................................................................................2285Isoprenalini hydrochloridum ....................................................2286Isoprenalini sulfas ........................................................................2287Isopropylis myristas .....................................................................2288Isopropylis palmitas .....................................................................2289Isosorbidi dinitras dilutus...........................................................2289Isosorbidi mononitras dilutus ...................................................2291Isotretinoinum ...............................................................................2293Isoxsuprini hydrochloridum ......................................................2294Isradipinum ....................................................................................2296

Itraconazolum................................................................................2297Iuniperi aetheroleum ................................................................... 1160Iuniperi pseudo-fructus ............................................................... 1160Ivermectinum.................................................................................2299

JJosamycini propionas ..................................................................2307Josamycinum .................................................................................2305

KKalii acetas ..................................................................................... 2761Kalii bromidum.............................................................................. 2761Kalii carbonas ................................................................................2762Kalii chloridum..............................................................................2763Kalii citras .......................................................................................2763Kalii clavulanas .............................................................................2764Kalii clavulanas dilutus...............................................................2766Kalii dihydrogenophosphas .......................................................2768Kalii hydrogenoaspartas hemihydricus ..................................2768Kalii hydrogenocarbonas............................................................2769Kalii hydrogenotartras.................................................................2769Kalii hydroxidum ..........................................................................2770Kalii iodidum .................................................................................2771Kalii metabisulfis ..........................................................................2771Kalii natrii tartras tetrahydricus...............................................2774Kalii nitras ......................................................................................2772Kalii perchloras .............................................................................2773Kalii permanganas .......................................................................2773Kalii sorbas .....................................................................................2774Kalii sulfas ......................................................................................2775Kanamycini monosulfas ............................................................. 2313Kanamycini sulfas acidus ........................................................... 2313Kaolinum ponderosum................................................................ 2314Ketamini hydrochloridum .......................................................... 2315Ketoconazolum .............................................................................. 2317Ketoprofenum ................................................................................ 2318Ketorolacum trometamolum ......................................................2320Ketotifeni hydrogenofumaras ....................................................2321Kryptonum (81mKr) ad inhalationem ........................................ 983

LLabetaloli hydrochloridum .........................................................2327Lacca ................................................................................................2901Lactitolum monohydricum.........................................................2329Lactosum anhydricum.................................................................2331Lactosum monohydricum...........................................................2333Lactulosum .....................................................................................2334Lactulosum liquidum ...................................................................2336Lamivudinum ................................................................................2337Lamotriginum................................................................................2339Lansoprazolum..............................................................................2341Lanugo cellulosi absorbens........................................................3207Lanugo gossypii absorbens ........................................................ 1768Lauromacrogolum 400................................................................2342Lavandulae aetheroleum ............................................................ 1164Lavandulae flos ............................................................................. 1163Leflunomidum ...............................................................................2345Leonuri cardiacae herba............................................................. 1190Letrozolum......................................................................................2347Leucinum ........................................................................................2348Leuprorelinum...............................................................................2348Levamisoli hydrochloridum .......................................................2351Levamisolum ad usum veterinarium ......................................2350Levetiracetamum...........................................................................2352Levistici radix................................................................................. 1172Levocabastini hydrochloridum .................................................2354Levocarnitinum .............................................................................2355Levodopum .....................................................................................2356Levodropropizinum......................................................................2358Levomentholum.............................................................................2359Levomepromazini hydrochloridum .........................................2360Levomepromazini maleas ..........................................................2361



Levomethadoni hydrochloridum ..............................................2362Levonorgestrelum .........................................................................2363Levothyroxinum natricum .........................................................2364Lichen islandicus .......................................................................... 1152Lidocaini hydrochloridum .........................................................2366Lidocainum ....................................................................................2365Limonis aetheroleum ................................................................... 1165Lincomycini hydrochloridum....................................................2367Lini oleum virginale ....................................................................2369Lini semen ...................................................................................... 1168Liothyroninum natricum ...........................................................2370Liquiritiae extractum fluidum ethanolicum normatum..... 1170Liquiritiae extractum siccum ad saporandum ...................... 1169Liquiritiae radix ............................................................................ 1171Lisinoprilum dihydricum ...........................................................2371Lithii carbonas...............................................................................2372Lithii citras .....................................................................................2373L-Methionini ([11C]methyl) solutio iniectabilis ........................ 985Lobelini hydrochloridum ............................................................2373Lomustinum ...................................................................................2375Loperamidi hydrochloridum......................................................2376Loperamidi oxidum monohydricum........................................2378Loratadinum ..................................................................................2379Lorazepamum ................................................................................2381Losartanum kalicum ....................................................................2382Lovastatinum .................................................................................2384Lufenuronum anhydricum ad usum veterinarium .............2385Lupuli flos ....................................................................................... 1151Lymecyclinum ...............................................................................2387Lynestrenolum ...............................................................................2389Lysini acetas...................................................................................2390Lysini hydrochloridum................................................................2391Lythri herba.................................................................................... 1172

MMacrogol 20 glyceroli monostearas .........................................2397Macrogol 40 sorbitoli heptaoleas ..............................................2404Macrogol 6 glyceroli caprylocapras .........................................2395Macrogola........................................................................................2402Macrogolglyceridorum caprylocaprates .................................1572Macrogolglyceridorum laurates ................................................2344Macrogolglyceridorum linoleates .............................................2368Macrogolglyceridorum oleates .................................................. 2610Macrogolglyceridorum stearates...............................................2990Macrogolglyceroli cocoates ........................................................2396Macrogolglyceroli hydroxystearas............................................2397Macrogolglyceroli ricinoleas......................................................2398Macrogoli 15 hydroxystearas .....................................................2399Macrogoli aether cetostearylicus ..............................................2395Macrogoli aether laurilicus ........................................................2400Macrogoli aether oleicus .............................................................2401Macrogoli aether stearylicus......................................................2405Macrogoli oleas..............................................................................2400Macrogoli stearas ..........................................................................2405Magaldratum ..................................................................................2406Magnesii acetas tetrahydricus ...................................................2407Magnesii aspartas dihydricus ....................................................2408Magnesii chloridum 4.5-hydricum ........................................... 2410Magnesii chloridum hexahydricum ......................................... 2411Magnesii citras anhydricus ........................................................ 2411Magnesii citras dodecahydricus................................................2412Magnesii citras nonahydricus ...................................................2412Magnesii gluconas ........................................................................ 2413Magnesii glycerophosphas ......................................................... 2414Magnesii hydroxidum .................................................................. 2414Magnesii lactas dihydricus ......................................................... 2415Magnesii oxidum leve .................................................................. 2416Magnesii oxidum ponderosum .................................................. 2415Magnesii peroxidum..................................................................... 2417Magnesii pidolas ........................................................................... 2417Magnesii stearas ............................................................................ 2418Magnesii subcarbonas levis........................................................2409

Magnesii subcarbonas ponderosus ..........................................2409Magnesii sulfas heptahydricus ..................................................2421Magnesii trisilicas .........................................................................2421Malathionum ..................................................................................2423Maltitolum .......................................................................................2425Maltitolum liquidum.....................................................................2427Maltodextrinum .............................................................................2428Malvae folium................................................................................. 1174Malvae sylvestris flos ................................................................... 1173Mangani gluconas ........................................................................2428Mangani glycerophosphas hydricus ........................................2429Mangani sulfas monohydricus ..................................................2430Mannitolum ....................................................................................2430Maprotilini hydrochloridum ......................................................2432Marbofloxacinum ad usum veterinarium ..............................2433Marrubii herba...............................................................................1265Masticabilia gummis medicata.................................................... 709Mastix ............................................................................................... 1177Matricariae aetheroleum............................................................. 1180Matricariae extractum fluidum ................................................. 1179Matricariae flos ............................................................................. 1178Maydis amylum .............................................................................2422Maydis oleum raffinatum............................................................2422Mebendazolum...............................................................................2434Meclozini dihydrochloridum .....................................................2435Medroxyprogesteroni acetas ......................................................2437Mefloquini hydrochloridum .......................................................2440Megestroli acetas ...........................................................................2441Megluminum ..................................................................................2442Mel..................................................................................................... 2163Melaleucae aetheroleum ............................................................. 1251Meliloti herba ................................................................................. 1183Melissae folii extractum siccum ................................................ 1185Melissae folium .............................................................................. 1184Meloxicamum.................................................................................2443Menadionum ..................................................................................2444Menthae arvensis aetheroleum partim mentholumdepletum........................................................................................ 1189

Menthae piperitae aetheroleum ................................................ 1214Menthae piperitae folii extractum siccum.............................. 1213Menthae piperitae folium ........................................................... 1212Mentholum racemicum ...............................................................2445Menyanthidis trifoliatae folium ................................................1080Mepivacaini hydrochloridum ....................................................2446Meprobamatum..............................................................................2447Mepyramini maleas ......................................................................2448Mercaptopurinum .........................................................................2449Meropenemum trihydricum .......................................................2450Mesalazinum ..................................................................................2451Mesnum ...........................................................................................2453Mesterolonum ................................................................................2454Mestranolum...................................................................................2455Metacresolum .................................................................................2456Metamizolum natricum ...............................................................2457Metformini hydrochloridum ......................................................2458Methadoni hydrochloridum .......................................................2462Methanolum....................................................................................2463Methaqualonum ............................................................................2464Methenaminum .............................................................................2465Methioninum..................................................................................2466Methotrexatum ...............................................................................2467Methylatropini bromidum...........................................................2469Methylatropini nitras ...................................................................2470Methylcellulosum ..........................................................................2471Methyldopum .................................................................................2472Methyleni chloridum ....................................................................2474Methylergometrini maleas ..........................................................2475Methylhydroxyethylcellulosum..................................................2476Methylis nicotinas .........................................................................2477Methylis parahydroxybenzoas ...................................................2477Methylis parahydroxybenzoas natricus ..................................2934Methylis salicylas ..........................................................................2488Methylphenidati hydrochloridum.............................................2479



Methylphenobarbitalum ..............................................................2480Methylprednisoloni acetas ..........................................................2483Methylprednisoloni hydrogenosuccinas .................................2485Methylprednisolonum ..................................................................2481Methylrosanilinii chloridum ......................................................2487Methyltestosteronum ....................................................................2489Methylthioninii chloridum .........................................................2490Metixeni hydrochloridum ...........................................................2491Metoclopramidi hydrochloridum ..............................................2493Metoclopramidum .........................................................................2492Metolazonum..................................................................................2494Metoprololi succinas ....................................................................2495Metoprololi tartras ........................................................................2497Metrifonatum..................................................................................2498Metronidazoli benzoas ................................................................2500Metronidazolum ............................................................................2500Mexiletini hydrochloridum.........................................................2502Mianserini hydrochloridum .......................................................2503Miconazoli nitras ..........................................................................2506Miconazolum..................................................................................2504Midazolamum ................................................................................2508Millefolii herba...............................................................................1271Minocyclini hydrochloridum dihydricum .............................. 2510Minoxidilum ................................................................................... 2511Mirtazapinum ................................................................................ 2512Misoprostolum ............................................................................... 2513Mitomycinum ................................................................................. 2515Mitoxantroni hydrochloridum ................................................... 2517Modafinilum ................................................................................... 2518Molgramostimi solutio concentrata ......................................... 2519Molsidominum ...............................................................................2521Mometasoni furoas .......................................................................2523Moranteli hydrogenotartras ad usum veterinarium ............2525Morphini hydrochloridum ..........................................................2526Morphini sulfas..............................................................................2527Moxidectinum ad usum veterinarium .....................................2529Moxifloxacini hydrochloridum .................................................2531Moxonidinum .................................................................................2532Mupirocinum..................................................................................2533Mupirocinum calcicum ...............................................................2535Musci medicati................................................................................. 712Mycophenolas mofetil ..................................................................2536myo-Inositolum..............................................................................2236Myristicae fragrantis aetheroleum ........................................... 1199Myrrha ............................................................................................. 1192Myrrhae tinctura ........................................................................... 1192Myrtilli fructus recens..................................................................1070Myrtilli fructus recentis extractum siccum raffinatum etnormatum ..................................................................................... 1130

Myrtilli fructus siccus ..................................................................1070

NNabumetonum ...............................................................................2541N-Acetyltryptophanum................................................................. 1319N-Acetyltyrosinum ........................................................................1320Nadololum.......................................................................................2542Nadroparinum calcicum .............................................................2543Naftidrofuryli hydrogenooxalas ................................................2545Naloxoni hydrochloridum dihydricum ...................................2548Naltrexoni hydrochloridum ........................................................2549Nandroloni decanoas ...................................................................2551Naphazolini hydrochloridum ....................................................2552Naphazolini nitras ........................................................................2553Naproxenum ...................................................................................2554Naproxenum natricum ................................................................2556Nasalia ............................................................................................... 719Natrii acetas trihydricus .............................................................2908Natrii acetatis ([1-11C]) solutio iniectabilis ............................... 990Natrii alendronas ..........................................................................2908Natrii alginas .................................................................................2909Natrii amidotrizoas ...................................................................... 2910Natrii aminosalicylas dihydricus.............................................. 2911

Natrii ascorbas ............................................................................... 2912Natrii aurothiomalas .................................................................... 2914Natrii benzoas ................................................................................ 2915Natrii bromidum............................................................................ 2915Natrii calcii edetas ........................................................................ 2916Natrii calcii pentetas ad radiopharmaceutica......................... 987Natrii caprylas ............................................................................... 2917Natrii carbonas anhydricus ....................................................... 2918Natrii carbonas decahydricus.................................................... 2919Natrii carbonas monohydricus.................................................. 2919Natrii cetylo- et stearylosulfas. ..................................................2920Natrii chloridum............................................................................2921Natrii chromatis (51Cr) solutio sterilis ....................................... 991Natrii citras .....................................................................................2922Natrii cromoglicas ........................................................................2923Natrii cyclamas ..............................................................................2924Natrii dihydrogenophosphas dihydricus ................................2925Natrii docusas ................................................................................1883Natrii fluoridi (18F) solutio iniectabilis...................................... 991Natrii fluoridum ............................................................................2925Natrii fusidas ..................................................................................2926Natrii glycerophosphas hydricus ..............................................2927Natrii hyaluronas ..........................................................................2927Natrii hydrogenocarbonas..........................................................2929Natrii hydroxidum ........................................................................2930Natrii iodidi (123I) solutioad radio-signandum ........................ 993Natrii iodidi (123I) solutio iniectabilis ........................................ 992Natrii iodidi (131I) capsulae ad usum diagnosticum............... 994Natrii iodidi (131I) capsulae ad usum therapeuticum............. 995Natrii iodidi (131I) solutio............................................................... 996Natrii iodidi (131I) solutio ad radio-signandum ....................... 996Natrii iodidum ...............................................................................2930Natrii iodohippurati (123I) solutio iniectabilis ......................... 997Natrii iodohippurati (131I) solutio iniectabilis.......................... 998Natrii lactatis solutio ....................................................................2931Natrii laurilsulfas ..........................................................................2933Natrii metabisulfis ........................................................................2933Natrii molybdas dihydricus ........................................................2935Natrii molybdatis (99Mo) fissione formati solutio ................... 999Natrii nitris .....................................................................................2936Natrii nitroprussias ......................................................................2936Natrii perboras hydricus .............................................................2937Natrii pertechnetatis (99mTc) fissione formati solutioiniectabilis .................................................................................... 1001

Natrii pertechnetatis (99mTc) sine fissione formati solutioiniectabilis ....................................................................................1002

Natrii phenylbutyras ....................................................................2938Natrii phosphatis (32P) solutio iniectabilis .............................1003Natrii picosulfas ............................................................................2939Natrii polystyrenesulfonas..........................................................2940Natrii propionas ............................................................................2941Natrii salicylas ...............................................................................2943Natrii selenis pentahydricus ......................................................2944Natrii (S)-lactatis solutio .............................................................2932Natrii stearas ..................................................................................2947Natrii stearylis fumaras...............................................................2948Natrii sulfas anhydricus ..............................................................2948Natrii sulfas decahydricus ..........................................................2949Natrii sulfis anhydricus...............................................................2950Natrii sulfis heptahydricus .........................................................2950Natrii thiosulfas .............................................................................2951Natrii valproas ...............................................................................2951Neohesperidin-dihydrochalconum ...........................................2558Neomycini sulfas ...........................................................................2559Neostigmini bromidum................................................................2560Neostigmini metilsulfas ...............................................................2561Neroli aetheroleum ....................................................................... 1194Netilmicini sulfas ..........................................................................2562Nevirapinum anhydricum ..........................................................2563Nicergolinum .................................................................................2564Nicethamidum ...............................................................................2575Niclosamidum anhydricum........................................................2565Niclosamidum monohydricum..................................................2566



Nicotinamidum..............................................................................2567Nicotini resinas .............................................................................2568Nicotinum .......................................................................................2567Nifedipinum....................................................................................2571Nifuroxazidum ...............................................................................2574Nilutamidum ..................................................................................2575Nimesulidum ..................................................................................2577Nimodipinum .................................................................................2578Nitrazepamum ...............................................................................2579Nitrendipinum ...............................................................................2580Nitrofuralum...................................................................................2582Nitrofurantoinum..........................................................................2583Nitrogenii oxidum.........................................................................2581Nitrogenium ...................................................................................2584Nitrogenium oxygenio depletum ..............................................2585Nizatidinum....................................................................................2586N-Methylpyrrolidonum ................................................................2486Nomegestroli acetas......................................................................2588Nonoxinolum 9 ..............................................................................2589Noradrenalini hydrochloridum .................................................2589Noradrenalini tartras ...................................................................2591Norethisteroni acetas ...................................................................2594Norethisteronum ...........................................................................2592Norfloxacinum...............................................................................2595Norgestimatum ..............................................................................2596Norgestrelum ..................................................................................2597Nortriptylini hydrochloridum....................................................2598Noscapini hydrochloridum.........................................................2600Noscapinum....................................................................................2599Notoginseng radix......................................................................... 1197Nystatinum .....................................................................................2602

OOctoxinolum 10 .............................................................................2607Octyldodecanolum ........................................................................2608Octylis gallas ..................................................................................2607Oenotherae oleum raffinatum ................................................... 1991Ofloxacinum ...................................................................................2609Oleae folii extractum siccum...................................................... 1201Oleae folium ...................................................................................1200Olea herbaria .................................................................................. 703Olibanum indicum........................................................................ 1152Olivae oleum raffinatum .............................................................2612Olivae oleum virginale ................................................................ 2613Olsalazinum natricum................................................................. 2613Omega-3 acidorum esteri ethylici 60....................................... 2616Omega-3 acidorum esteri ethylici 90....................................... 2617Omega-3 acidorum triglycerida ................................................ 2619Omeprazolum.................................................................................2621Omeprazolum magnesicum .......................................................2623Omeprazolum natricum ..............................................................2624Ondansetroni hydrochloridum dihydricum ..........................2625Ononidis radix ...............................................................................1223Ophthalmica ..................................................................................... 710Opii extractum siccum normatum............................................1202Opii pulvis normatus ...................................................................1203Opii tinctura normata..................................................................1205Opium crudum ..............................................................................1204Orbifloxacinum ad usum veterinarium ..................................2627Orciprenalini sulfas ......................................................................2628Origani herba .................................................................................1206Orphenadrini citras ......................................................................2630Orphenadrini hydrochloridum..................................................2631Orthosiphonis folium ................................................................... 1158Oryzae amylum .............................................................................2855Ouabainum .....................................................................................2632Oxacillinum natricum monohydricum ...................................2633Oxaliplatinum ................................................................................2635Oxazepamum .................................................................................2638Oxeladini hydrogenocitras .........................................................2639Oxfendazolum ad usum veterinarium ....................................2640Oxitropii bromidum......................................................................2641

Oxprenololi hydrochloridum ....................................................2643Oxybuprocaini hydrochloridum ...............................................2644Oxybutynini hydrochloridum ....................................................2645Oxycodoni hydrochloridum .......................................................2646Oxygenium......................................................................................2648Oxygenium (15O) .............................................................................. 986Oxymetazolini hydrochloridum ................................................2648Oxytetracyclini hydrochloridum ...............................................2651Oxytetracyclinum dihydricum...................................................2649Oxytocini solutio concentrata....................................................2654Oxytocinum ....................................................................................2653

PPaclitaxelum ...................................................................................2657Pancreatis pulvis ...........................................................................2661Pancuronii bromidum .................................................................2663Pantoprazolum natricum sesquihydricum ............................2664Papaverini hydrochloridum .......................................................2666Papaveris rhoeados flos ..............................................................1222Paracetamolum..............................................................................2667Paraffinum liquidum....................................................................2669Paraffinum perliquidum .............................................................2669Paraffinum solidum......................................................................2668Paraldehydum ................................................................................2671Parenteralia ...................................................................................... 723Parnaparinum natricum.............................................................2672Paroxetini hydrochloridum anhydricum................................2672Paroxetini hydrochloridum hemihydricum ...........................2674Passiflorae herba...........................................................................1209Passiflorae herbae extractum siccum ...................................... 1210Pefloxacini mesilas dihydricus .................................................2677Pelargonii radix ............................................................................. 1211Penbutololi sulfas ..........................................................................2678Penicillaminum .............................................................................2679Pentaerythrityli tetranitras dilutus...........................................2681Pentamidini diisetionas ..............................................................2683Pentazocini hydrochloridum .....................................................2684Pentazocini lactas .........................................................................2685Pentazocinum ................................................................................2684Pentobarbitalum ............................................................................2685Pentobarbitalum natricum .........................................................2686Pentoxifyllinum .............................................................................2687Pentoxyverini hydrogenocitras .................................................2689Pepsini pulvis .................................................................................2690Pergolidi mesilas ...........................................................................2691Perphenazinum .............................................................................2697Pethidini hydrochloridum ..........................................................2698Phenazonum ..................................................................................2699Pheniramini maleas .....................................................................2700Phenobarbitalum...........................................................................2702Phenobarbitalum natricum ........................................................2702Phenolphthaleinum......................................................................2704Phenolsulfonphthaleinum ..........................................................2704Phenolum ........................................................................................2703Phenoxyethanolum ......................................................................2705Phenoxymethylpenicillinum......................................................2706Phenoxymethylpenicillinum kalicum .....................................2708Phentolamini mesilas ..................................................................2709Phenylalaninum............................................................................ 2711Phenylbutazonum......................................................................... 2711Phenylephrini hydrochloridum ................................................ 2714Phenylephrinum ...........................................................................2713Phenylhydrargyri acetas .............................................................2715Phenylhydrargyri boras............................................................... 2716Phenylhydrargyri nitras .............................................................. 2716Phenylpropanolamini hydrochloridum .................................. 2717Phenytoinum..................................................................................2718Phenytoinum natricum ...............................................................2719Phloroglucinolum anhydricum.................................................2720Phloroglucinolum dihydricum ..................................................2722Pholcodinum ..................................................................................2724Phthalylsulfathiazolum ...............................................................2726



Physostigmini salicylas ...............................................................2726Physostigmini sulfas ....................................................................2727Phytomenadionum .......................................................................2728Phytosterolum ................................................................................2729Picotamidum monohydricum....................................................2730Pilocarpini hydrochloridum ......................................................2731Pilocarpini nitras ..........................................................................2732Pimobendanum .............................................................................2734Pimozidum .....................................................................................2734Pindololum .....................................................................................2736Pini pumilionis aetheroleum ..................................................... 1116Pini sylvestris aetheroleum ........................................................ 1216Piperacillinum ..............................................................................2738Piperacillinum natricum ............................................................2739Piperazini adipas .......................................................................... 2741Piperazini citras ............................................................................2742Piperazinum hydricum ...............................................................2743Piracetamum ..................................................................................2743Pirenzepini dihydrochloridum monohydricum ...................2744Piretanidum....................................................................................2746Piroxicamum ..................................................................................2747Piscis oleum omega-3 acidis abundans .................................. 2019Pisi amylum....................................................................................2676Pivampicillinum ............................................................................2748Pivmecillinami hydrochloridum ..............................................2750Plantae ad ptisanam ...................................................................... 677Plantae medicinales ....................................................................... 676Plantae medicinales ad praeparationes homoeopathicas ..1275Plantae medicinales praeparatae ............................................... 676Plantaginis lanceolatae folium .................................................1225Plantaginis ovatae semen ........................................................... 1157Plantaginis ovatae seminis tegumentum ............................... 1156Plasma humanum ad separationem ........................................ 2181Plasma humanum coagmentatum conditumque adexstinguendum virum ............................................................... 2182

Poloxamera .....................................................................................2751Polyacrylatis dispersio 30 per centum....................................2752Poly(alcohol vinylicus) ................................................................2760Polygalae radix ..............................................................................1235Polygoni avicularis herba ........................................................... 1162Polymyxini B sulfas......................................................................2753Polysorbatum 20 ...........................................................................2754Polysorbatum 40 ...........................................................................2755Polysorbatum 60 ...........................................................................2756Polysorbatum 80 ...........................................................................2756Poly(vinylis acetas) .......................................................................2758Poly(vinylis acetas) dispersio 30 per centum ........................2759Povidonum......................................................................................2776Povidonum iodinatum .................................................................2778Praeadmixta ad alimentamedicata ad usum veterinarium .. 727Praeparationes ad irrigationem.................................................. 731Praeparationes buccales ............................................................... 721Praeparationes homoeopathicae ..............................................1275Praeparationes insulini iniectabiles ........................................2249Praeparationes intramammariae ad usum veterinarium .... 714Praeparationes intraruminales ................................................... 715Praeparationes intra-uterinae ad usum veterinarium .......... 715Praeparationes liquidae ad usum dermicum .......................... 717Praeparationes liquidae peroraliae............................................ 718Praeparationes liquidae veterinariae ad usum dermicum .. 740Praeparationes molles ad usum dermicum ............................. 734Praeparationes pharmaceuticae in vasis cum pressu........... 732Pramipexoli dihydrochloridum monohydricum...................2779Pravastatinum natricum .............................................................2780Prazepamum ..................................................................................2782Praziquantelum .............................................................................2783Prazosini hydrochloridum .........................................................2784Prednicarbatum.............................................................................2785Prednisoloni acetas ......................................................................2787Prednisoloni natrii phosphas ....................................................2790Prednisoloni pivalas.....................................................................2789Prednisolonum ..............................................................................2786Prednisonum ..................................................................................2791

Prilocaini hydrochloridum.........................................................2794Prilocainum....................................................................................2792Primaquini diphosphas ...............................................................2795Primidonum ...................................................................................2796Primulae radix ............................................................................... 1217Probenecidum ................................................................................2797Procainamidi hydrochloridum..................................................2798Procaini hydrochloridum ...........................................................2798Prochlorperazini maleas.............................................................2799Producta ab arte ADN recombinandorum ............................... 692Producta ab fermentatione ........................................................... 685Producta allergenica ...................................................................... 671Producta cum possibili transmissione vectoriumenkephalopathiarum spongiformium animalium ............... 686

Progesteronum ..............................................................................2800Proguanili hydrochloridum .......................................................2801Prolinum .........................................................................................2802Promazini hydrochloridum........................................................2803Promethazini hydrochloridum..................................................2804Propacetamoli hydrochloridum ................................................2805Propafenoni hydrochloridum ....................................................2806Propanolum....................................................................................2808Propanthelini bromidum ............................................................2809Propofolum ..................................................................................... 2810Propranololi hydrochloridum.................................................... 2811Propylenglycoli dicaprylocapras .............................................. 2815Propylenglycoli dilauras ............................................................. 2815Propylenglycoli monolauras ...................................................... 2816Propylenglycoli monopalmitostearas ...................................... 2817Propylenglycolum ......................................................................... 2814Propylis gallas................................................................................2812Propylis parahydroxybenzoas ................................................... 2813Propylis parahydroxybenzoas natricus ..................................2942Propylthiouracilum ...................................................................... 2818Propyphenazonum ....................................................................... 2819Protamini hydrochloridum ........................................................2820Protamini sulfas ............................................................................2821Prothrombinum multiplex humanum ..................................... 2185Protirelinum ...................................................................................2822Proxyphyllinum.............................................................................2823Pruni africanae cortex ................................................................1221Pseudoephedrini hydrochloridum ...........................................2824Psyllii semen .................................................................................. 1217Pulveres ad usum dermicum ....................................................... 726Pulveres perorales........................................................................... 727Pyranteli embonas ........................................................................2825Pyrazinamidum.............................................................................2826Pyridostigmini bromidum ..........................................................2827Pyridoxini hydrochloridum .......................................................2827Pyrimethaminum ..........................................................................2829Pyrrolidonum.................................................................................2829

QQuercus cortex ............................................................................... 1199

RRacecadotrilum..............................................................................2841Raclopridi ([11C]methoxy) solutio iniectabilis ......................... 988Radiopharmaceutica ...................................................................... 686Raloxifeni hydrochloridum ........................................................2842Ramiprilum ....................................................................................2843Ranitidini hydrochloridum ........................................................2845Rapae oleum raffinatum .............................................................2847Ratanhiae radix .............................................................................1223Ratanhiae tinctura........................................................................1224Rectalia .............................................................................................. 732Repaglinidum.................................................................................2847Reserpinum ....................................................................................2849Resorcinolum .................................................................................2850Rhamni purshianae cortex.........................................................1092Rhamni purshianae extractum siccum normatum..............1094Rhei radix........................................................................................1224



Rhenii sulfidi colloidalis et technetii (99mTc) solutioiniectabilis ....................................................................................1005

Ribavirinum ...................................................................................2850Riboflavini natrii phosphas .......................................................2853Riboflavinum..................................................................................2852Ricini oleum hydrogenatum ......................................................1596Ricini oleum raffinatum..............................................................1597Ricini oleum virginale .................................................................1598Rifabutinum....................................................................................2855Rifampicinum ................................................................................2856Rifamycinum natricum ...............................................................2858Rifaximinum ..................................................................................2859Rilmenidini dihydrogenophosphas..........................................2861Risperidonum ................................................................................2861Ritonavirum ...................................................................................2863Rocuronii bromidum....................................................................2866Ropivacaini hydrochloridum monohydricum ......................2868Rosae pseudo-fructus ................................................................... 1115Rosmarini aetheroleum...............................................................1228Rosmarini folium ..........................................................................1227Roxithromycinum .........................................................................2869RRR-α-Tocopherolum .................................................................. 3105RRR-α-Tocopherylis acetas ........................................................ 3108RRR-α-Tocopherylis hydrogenosuccinas................................ 3111Rusci rhizoma................................................................................1085Rutosidum trihydricum ...............................................................2871

SSabalis serrulatae fructus ...........................................................1233Sacchari monopalmitas ..............................................................2998Saccharinum ..................................................................................2877Saccharinum natricum ...............................................................2878Sacchari sphaerae ........................................................................3002Sacchari stearas ............................................................................2999Saccharum ......................................................................................2996Salbutamoli sulfas .......................................................................2881Salbutamolum ................................................................................2879Salicis cortex ..................................................................................1268Salicis corticis extractum siccum .............................................1269Salmeteroli xinafoas ....................................................................2885Salmonis domestici oleum .........................................................2886Salviae lavandulifoliae aetheroleum .......................................1239Salviae officinalis folium ............................................................1230Salviae sclareae aetheroleum .................................................... 1104Salviae tinctura ............................................................................. 1231Salviae trilobae folium ................................................................ 1231Sambuci flos ................................................................................... 1117Sanguisorbae radix ......................................................................1232Saquinaviri mesilas......................................................................2889Schisandrae chinensis fructus ..................................................1234Scopolamini butylbromidum ..................................................... 2215Scopolamini hydrobromidum.................................................... 2216Scopolaminum............................................................................... 2214Selamectinum ad usum veterinarium.....................................2890Selegilini hydrochloridum..........................................................2892Selenii disulfidum.........................................................................2893Semecarpus anacardiumad praeparationes homoeopathicas.......................................1295

Sennae folii extractum siccum normatum.............................1237Sennae folium................................................................................1236Sennae fructus acutifoliae..........................................................1238Sennae fructus angustifoliae .....................................................1238Serinum ...........................................................................................2893Serpylli herba.................................................................................1267Sertaconazoli nitras .....................................................................2894Sertralini hydrochloridum .........................................................2895Serum bovinum .............................................................................1506Sesami oleum raffinatum ...........................................................2898Sevofluranum ................................................................................2899Silica ad usum dentalem.............................................................2903Silica colloidalis anhydrica........................................................2901Silica colloidalis hydrica.............................................................2902

Silica hydrophobica colloidalis .................................................2903Silybi mariani extractum siccum raffinatum etnormatum ..................................................................................... 1186

Silybi mariani fructus.................................................................. 1187Simeticonum ..................................................................................2905Simvastatinum ...............................................................................2906Soiae oleum hydrogenatum .......................................................2968Soiae oleum raffinatum ..............................................................2969Solani amylum ..............................................................................2775Solidaginis herba .......................................................................... 1141Solidaginis virgaureae herba..................................................... 1142Solutiones ad conservationem partium corporis .................2952Solutiones ad haemocolaturam haemodiacolaturamque .. 2138Solutiones ad haemodialysim ................................................... 2136Solutiones ad peritonealem dialysim ......................................2695Solutiones anticoagulantes et sanguinem humanumconservantes ................................................................................ 1401

Somatostatinum ............................................................................2953Somatropini solutio concentrata ..............................................2956Somatropinum ...............................................................................2954Somatropinum iniectabile ..........................................................2958Sorbitani lauras .............................................................................2961Sorbitani oleas ...............................................................................2961Sorbitani palmitas ........................................................................2962Sorbitani sesquioleas ...................................................................2962Sorbitani stearas ...........................................................................2962Sorbitani trioleas ..........................................................................2963Sorbitolum ......................................................................................2963Sorbitolum liquidum cristallisabile..........................................2965Sorbitolum liquidum non cristallisabile .................................2965Sorbitolum liquidum partim deshydricum ............................2966Sotaloli hydrochloridum .............................................................2967Spectinomycini dihydrochloridum pentahydricum ............2969Spectinomycini sulfas tetrahydricus ad usumveterinarium ................................................................................2971

Spicae aetheroleum ......................................................................1240Spiramycinum ...............................................................................2973Spiraprili hydrochloridum monohydricum ...........................2975Spironolactonum ..........................................................................2976Squalanum......................................................................................2978Stanni colloidalis et technetii (99mtc) solutio iniectabilis....1006Stanni pyrophosphatis et technetii (99mTc) solutioiniectabilis .................................................................................... 1019

Stannosi chloridum dihydricum...............................................2980Stanozololum .................................................................................2981Stavudinum ....................................................................................2988Stephaniae tetrandrae radix ......................................................1127Stramonii folium ...........................................................................1247Stramonii pulvis normatus.........................................................1248Streptokinasi solutio concentrata.............................................2991Streptomycini sulfas.....................................................................2993Strontii (89Sr) chloridi solutio iniectabilis ..............................1003Styli ..................................................................................................... 736Succinylsulfathiazolum ...............................................................2994Sucralfatum ....................................................................................2995Sufentanili citras ...........................................................................3001Sufentanilum..................................................................................3000Sulbactamum natricum...............................................................3003Sulfacetamidum natricum ..........................................................3005Sulfadiazinum ...............................................................................3006Sulfadimidinum.............................................................................3007Sulfadoxinum.................................................................................3007Sulfafurazolum ..............................................................................3008Sulfaguanidinum ..........................................................................3009Sulfamerazinum ............................................................................ 3010Sulfamethizolum ........................................................................... 3011Sulfamethoxazolum...................................................................... 3011Sulfamethoxypyridazinum ad usum veterinarium ............. 3013Sulfanilamidum............................................................................. 3013Sulfasalazinum .............................................................................. 3014Sulfathiazolum .............................................................................. 3016Sulfinpyrazonum .......................................................................... 3017Sulfisomidinum ............................................................................. 3018



Sulfur ad usum externum ........................................................... 3019Sulfuris colloidalis et technetii (99mTc) solutio iniectabilis ..1006Sulindacum ....................................................................................3020Sulpiridum ......................................................................................3021Sultamicillini tosilas dihydricus ...............................................3024Sultamicillinum.............................................................................3022Sumatriptani succinas.................................................................3026Suxamethonii chloridum ............................................................3028Suxibuzonum .................................................................................3029

TTalcum .............................................................................................3033Tamoxifeni citras...........................................................................3034Tamponae medicatae ..................................................................... 738Tamsulosini hydrochloridum ....................................................3036Tanaceti parthenii herba ............................................................1126Tanninum .......................................................................................3037Taraxaci officinalis herba cum radice ..................................... 1110Taraxaci officinalis radix ............................................................ 1111Technetii (99mTc) bicisati solutio iniectabilis..........................1004Technetii (99mTc) et etifenini solutio iniectabilis ...................1007Technetii (99mTc) exametazimi solutio iniectabilis ...............1008Technetii (99mTc) gluconatis solutio iniectabilis....................1009Technetii (99mTc) humani albumini solutio iniectabilis ...... 1010Technetii (99mTc) macrosalbi suspensio iniectabilis............. 1011Technetii (99mTc) mebrofenini solutio iniectabilis ................ 1012Technetii (99mTc) medronati solutio iniectabilis.................... 1013Technetii (99mTc) mertiatidi solutio iniectabilis..................... 1014Technetii (99mTc) microsphaerarum suspensioiniectabilis .................................................................................... 1015

Technetii (99mTc) pentetatis solutio iniectabilis ..................... 1016Technetii (99mTc) sestamibi solutio iniectabilis...................... 1017Technetii (99mTc) succimeri solutio iniectabilis ..................... 1018Teicoplaninum...............................................................................3038Telmisartanum...............................................................................3040Temazepamum ..............................................................................3042Tenoxicamum ................................................................................3043Terazosini hydrochloridum dihydricum.................................3045Terbinafini hydrochloridum ......................................................3047Terbutalini sulfas ..........................................................................3048Terconazolum ................................................................................3049Terebinthinae aetheroleum a Pino pinastro..........................1258Terfenadinum.................................................................................3050tert-Butylamini perindoprilum..................................................2692Testosteroni decanoas..................................................................3053Testosteroni enantas ....................................................................3054Testosteroni isocaproas ...............................................................3056Testosteroni propionas ................................................................3057Testosteronum................................................................................3052Tetracaini hydrochloridum ........................................................3058Tetracosactidum ............................................................................3059Tetracyclini hydrochloridum .....................................................3061Tetracyclinum ................................................................................3060Tetra-O-acetylmannosi triflas ad radiopharmaceutica .......1020Tetrazepamum ...............................................................................3063Tetryzolini hydrochloridum .......................................................3064Thallosi (201Tl) chloridi solutio iniectabilis............................. 1021Theobrominum ..............................................................................3065Theophyllinum...............................................................................3065Theophyllinum et ethylenediaminum anhydricum.............3068Theophyllinum et ethylenediaminum hydricum..................3069Theophyllinum monohydricum ................................................3066Thiamazolum .................................................................................3071Thiamini hydrochloridum ..........................................................3072Thiamini nitras ..............................................................................3073Thiamphenicolum.........................................................................3074Thiomersalum ................................................................................3076Thiopentalum natricum et natrii carbonas ...........................3077Thioridazini hydrochloridum ....................................................3079Thioridazinum ...............................................................................3078Threoninum....................................................................................3080Thymi aetheroleum ......................................................................1254

Thymi herba ...................................................................................1252Thymolum .......................................................................................3081Tiabendazolum ..............................................................................3081Tiamulini hydrogenofumaras ad usum veterinarium ........3084Tiamulinum ad usum veterinarium ........................................3082Tianeptinum natricum ................................................................3086Tiapridi hydrochloridum ............................................................3087Tibolonum .......................................................................................3090Ticarcillinum natricum ...............................................................3091Ticlopidini hydrochloridum .......................................................3092Tiliae flos......................................................................................... 1168Tilidini hydrochloridum hemihydricum.................................3094Timololi maleas .............................................................................3095Tincturae maternae ad praeparationes homoeopathicas ..1286Tinidazolum ...................................................................................3097Tinzaparinum natricum .............................................................3098Tioconazolum ................................................................................3099Tiotropii bromidum monohydricum........................................ 3100Titanii dioxidum............................................................................ 3101Tobramycinum............................................................................... 3103α-Tocopherylis acetatis pulvis ................................................... 3109Tolbutamidum ................................................................................ 3113Tolnaftatum .................................................................................... 3115Torasemidum anhydricum ......................................................... 3117Tormentillae rhizoma ..................................................................1255Tormentillae tinctura ...................................................................1256Tosylchloramidum natricum ..................................................... 3118Toxinum botulinicum typum A ad iniectabile ......................1504Tragacantha....................................................................................1256Tramadoli hydrochloridum ........................................................ 3118Tramazolini hydrochloridum monohydricum ...................... 3120Trandolaprilum ............................................................................. 3120Trapidilum ...................................................................................... 3123Trehalosum dihydricum .............................................................. 3124Tretinoinum.................................................................................... 3125Triacetinum .................................................................................... 3127Triamcinoloni acetonidum......................................................... 3128Triamcinoloni hexacetonidum .................................................. 3130Triamcinolonum ........................................................................... 3127Triamterenum ................................................................................ 3131Tribenosidum ................................................................................. 3132Tributylis acetylcitras................................................................... 3133Tricalcii phosphas.........................................................................1567Triethylis citras .............................................................................. 3136Trifluoperazini hydrochloridum............................................... 3136Triflusalum ..................................................................................... 3137Triglycerida saturata media ....................................................... 3138Triglyceroli diisostearas .............................................................. 3140Trigonellae foenugraeci semen .................................................1126Trihexyphenidyli hydrochloridum ........................................... 3140Trimebutini maleas ...................................................................... 3141Trimetazidini dihydrochloridum .............................................. 3142Trimethadionum ........................................................................... 3144Trimethoprimum........................................................................... 3144Trimipramini maleas ................................................................... 3146Tri-n-butylis phosphas.................................................................. 3134Tritici aestivi oleum raffinatum ................................................3226Tritici aestivi oleum virginale....................................................3227Tritici amylum ...............................................................................3226Trolaminum.................................................................................... 3148Trometamolum .............................................................................. 3150Tropicamidum ............................................................................... 3151Tropisetroni hydrochloridum .................................................... 3152Trospii chloridum ......................................................................... 3154Troxerutinum ................................................................................. 3155Trypsinum....................................................................................... 3156Tryptophanum ............................................................................... 3157Tuberculini aviarii derivatum proteinosum purificatum .. 3161Tuberculini bovini derivatum proteinosum purificatum ... 3161Tuberculini derivatum proteinosum purificatum ad usumhumanum ..................................................................................... 3162

Tuberculinum pristinum ad usum humanum ...................... 3159Tubocurarini chloridum.............................................................. 3164



Tylosini phosphatis solutio ad usum veterinarium ............. 3166Tylosini tartras ad usum veterinarium ................................... 3168Tylosinum ad usum veterinarium ............................................ 3165Tyrosinum....................................................................................... 3169Tyrothricinum................................................................................ 3170

UUbidecarenonum ........................................................................... 3175Ureum............................................................................................... 3176Urofollitropinum ........................................................................... 3177Urokinasum .................................................................................... 3178Urtica dioica ad praeparationes homoeopathicas ...............1288Urticae folium ................................................................................ 1196Uvae ursi folium ............................................................................ 1061

VVaccina ad usum humanum ........................................................ 695Vaccina ad usum veterinarium ................................................... 698Vaccinum actinobacillosidis inactivatum ad suem................ 926Vaccinum adenovirosidis caninae vivum................................. 871Vaccinum adenovirosis caninae inactivatum ......................... 870Vaccinum anaemiae infectivae pulli vivum............................. 910Vaccinum anthracis adsorbatum ab colato culturarum adusum humanum ............................................................................ 745

Vaccinum anthracis vivum ad usum veterinarium................ 847Vaccinum aphtharum epizooticarum inactivatum adruminantes ..................................................................................... 904

Vaccinum bronchitidis infectivae aviariae inactivatum....... 851Vaccinum bronchitidis infectivae aviariae vivum .................. 852Vaccinum brucellosis (Brucella melitensis stirpe Rev. 1) vivumad usum veterinarium ................................................................. 867

Vaccinum bursitidis infectivae aviariae inactivatum............ 854Vaccinum bursitidis infectivae aviariae vivum ....................... 856Vaccinum calicivirosis felinae inactivatum ............................. 895Vaccinum calicivirosis felinae vivum ........................................ 896Vaccinum chlamydiosidis felinae inactivatum ....................... 897Vaccinum cholerae ......................................................................... 748Vaccinum cholerae aviariae inactivatum ................................. 905Vaccinum cholerae cryodesiccatum........................................... 749Vaccinum cholerae perorale inactivatum................................. 749Vaccinum Clostridii botulini ad usum veterinarium ............ 878Vaccinum Clostridii chauvoei ad usum veterinarium .......... 879Vaccinum Clostridii novyi B ad usum veterinarium............. 879Vaccinum Clostridii perfringentis ad usum veterinarium... 881Vaccinum Clostridii septici ad usum veterinarium ............... 883Vaccinum coccidiosidis vivum ad pullum ................................ 884Vaccinum colibacillosis fetus a partu recentis inactivatum adruminantes ..................................................................................... 920

Vaccinum colibacillosis fetus a partu recentis inactivatum adsuem ................................................................................................. 918

Vaccinum diarrhoeae viralis bovinae inactivatum ................ 866Vaccinum diphtheriae adsorbatum ............................................ 774Vaccinum diphtheriae, antigeniis minutum, adsorbatum ... 776Vaccinum diphtheriae et tetani adsorbatum ........................... 751Vaccinum diphtheriae et tetani, antigeni-o(-is) minutum,adsorbatum..................................................................................... 752

Vaccinum diphtheriae, tetani et hepatitidis B (ADNr)adsorbatum..................................................................................... 753

Vaccinum diphtheriae, tetani et pertussis adsorbatum ........ 755Vaccinum diphtheriae, tetani et pertussis sine cellulis exelementis praeparatum adsorbatum........................................ 754

Vaccinum diphtheriae, tetani et poliomyelitidis inactivatum,antigeni-o(-is) minutum, adsorbatum...................................... 756

Vaccinum diphtheriae, tetani, pertussis et poliomyelitidisinactivatum adsorbatum ............................................................. 771

Vaccinum diphtheriae, tetani, pertussis, poliomyelitidisinactivatum et haemophili stirpi b coniugatumadsorbatum..................................................................................... 772

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum cumque haemophili stirpi bconiugatum adsorbatum ............................................................. 758

Vaccinum diphtheriae, tetani, pertussis sine cellulisex elementis praeparatum et hepatitidis B (ADNr)adsorbatum ..................................................................................... 760

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et poliomyelitidis inactivatumadsorbatum ..................................................................................... 762

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et poliomyelitidis inactivatum,antigeni-o(-is) minutum, adsorbatum...................................... 763

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum, hepatitidis B (ADNr), poliomyelitidisinactivatum et haemophili stirpi b coniugatumadsorbatum ..................................................................................... 765

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum, poliomyelitidis inactivatum ethaemophili stirpi b coniugatum adsorbatum........................ 768

Vaccinum encephalitidis ixodibus advectae inactivatum .... 834Vaccinum encephalomyelitidis infectivae aviariae vivum .. 857Vaccinum erysipelatis suillae inactivatum .............................. 939Vaccinum febris flavae vivum...................................................... 840Vaccinum febris typhoidi .............................................................. 837Vaccinum febris typhoidi cryodesiccatum ............................... 837Vaccinum febris typhoidis polysaccharidicum ....................... 836Vaccinum febris typhoidis vivum perorale (stirpe Ty 21a) .. 838Vaccinum furunculosidis inactivatum ad salmonidas cumadiuvatione oleosa ad iniectionem .......................................... 907

Vaccinum haemophili stirpi b coniugatum ............................. 776Vaccinum hepatitidis A inactivatum adsorbatum .................. 780Vaccinum hepatitidis A inactivatum et hepatitidis B (ADNr)adsorbatum ..................................................................................... 779

Vaccinum hepatitidis A inactivatum virosomale .................... 781Vaccinum hepatitidis B (ADNr)................................................... 784Vaccinum hepatitidis viralis anatis stirpe I vivum ................ 889Vaccinum herpesviris equini inactivatum ............................... 892Vaccinum inactivatum diarrhoeae vituli coronaviroillatae ............................................................................................... 868

Vaccinum inactivatum diarrhoeae vituli rotaviro illatae..... 869Vaccinum influenzae equi inactivatum .................................... 893Vaccinum influenzae inactivatum ad suem ............................ 929Vaccinum influenzae inactivatum ex cellulis corticisqueantigeniis praeparatum............................................................... 791

Vaccinum influenzae inactivatum ex cellulis virisque integrispraeparatum................................................................................... 796

Vaccinum influenzae inactivatum ex corticis antigeniispraeparatum................................................................................... 789

Vaccinum influenzae inactivatum ex corticis antigeniispraeparatum virosomale............................................................. 793

Vaccinum influenzae inactivatum ex viris integrispraeparatum................................................................................... 795

Vaccinum influenzae inactivatum ex virorum fragmentispraeparatum................................................................................... 788

Vaccinum laryngotracheitidis infectivae aviariae vivum..... 859Vaccinum leptospirosis bovinae inactivatum .......................... 862Vaccinum leptospirosis caninae inactivatum ......................... 874Vaccinum leucosis felinae inactivatum..................................... 900Vaccinum mannheimiae inactivatum ad bovinas...................911Vaccinum mannheimiae inactivatum ad ovem ...................... 913Vaccinum meningococcale classis C coniugatum ................. 802Vaccinum meningococcale polysaccharidicum...................... 803Vaccinum morbi Aujeszkyi ad suem inactivatum .................. 847Vaccinum morbi Aujeszkyi ad suem vivum ad usumparenteralem .................................................................................. 849

Vaccinum morbi Carrei vivum ad canem................................. 872Vaccinum morbi Carrei vivum ad mustelidas ......................... 887Vaccinum morbi haemorrhagici cuniculi inactivatum ........ 933Vaccinum morbillorum, parotitidis et rubellae vivum .......... 798Vaccinum morbillorum, parotitidis, rubellae et varicellaevivum................................................................................................ 799

Vaccinum morbillorum vivum..................................................... 800Vaccinum morbi Marek vivum .....................................................914Vaccinum morbi partus diminutionis MCMLXXVI inactivatumad pullum ........................................................................................ 891

Vaccinum Mycoplasmatis galliseptici inactivatum ................ 916



Vaccinum myxomatosidis vivum ad cuniculum ......................917Vaccinum panleucopeniae felinae infectivae inactivatum .. 898Vaccinum panleucopeniae felinae infectivae vivum ............. 899Vaccinum papillomaviri humani (ADNr) ................................. 785Vaccinum parainfluenzae viri canini vivum........................... 875Vaccinum paramyxoviris 3 aviarii inactivatum ..................... 860Vaccinum parotitidis vivum ......................................................... 805Vaccinum parvovirosis caninae inactivatum .......................... 876Vaccinum parvovirosis caninae vivum ..................................... 877Vaccinum parvovirosis inactivatum ad suem ......................... 930Vaccinum pasteurellae inactivatum ad ovem.......................... 925Vaccinum pertussis ex cellulis integris adsorbatum.............. 810Vaccinum pertussis sine cellulis copurificatumadsorbatum..................................................................................... 808

Vaccinum pertussis sine cellulis ex elementis praeparatumadsorbatum..................................................................................... 806

Vaccinum pestis anatis vivum ..................................................... 888Vaccinum pestis classicae suillae vivum ex cellulis .............. 940Vaccinum pneumococcale polysaccharidicum ....................... 813Vaccinum pneumococcale polysaccharidicum coniugatumadsorbatum..................................................................................... 812

Vaccinum pneumoniae enzooticae suillae inactivatum ...... 927Vaccinum poliomyelitidis inactivatum ..................................... 815Vaccinum poliomyelitidis perorale ............................................ 818Vaccinum pseudopestis aviariae inactivatum ......................... 921Vaccinum pseudopestis aviariae vivum .................................... 923Vaccinum rabiei ex cellulis ad usum humanum .................... 822Vaccinum rabiei inactivatum ad usum veterinarium ........... 934Vaccinum rabiei perorale vivum ad vulpem ............................ 936Vaccinum rhinitidis atrophicantis ingravescentis suillaeinactivatum .................................................................................... 931

Vaccinum rhinotracheitidis infectivae bovinae vivum ......... 908Vaccinum rhinotracheitidis viralis felinae inactivatum ....... 901Vaccinum rhinotracheitidis viralis felinae vivum .................. 902Vaccinum rotaviri vivum perorale.............................................. 824Vaccinum rubellae vivum ............................................................. 827Vaccinum Salmonellae Enteritidis inactivatum ad pullum .. 937Vaccinum Salmonellae Typhimurium inactivatum adpullum.............................................................................................. 938

Vaccinum tenosynovitidis viralis aviariae vivum .................. 861Vaccinum tetani adsorbatum ....................................................... 833Vaccinum tetani ad usum veterinarium ................................... 941Vaccinum tuberculosis (BCG) cryodesiccatum ....................... 747Vaccinum varicellae vivum .......................................................... 839Vaccinum variolae gallinaceae vivum ..................................... 906Vaccinum variolae vivum ............................................................. 829Vaccinum vibriosidis aquae frigidae inactivatum adsalmonidas...................................................................................... 943

Vaccinum vibriosidis inactivatum ad salmonidas ................ 944Vaccinum viri parainfluenzae bovini vivum ........................... 864Vaccinum viri syncytialis meatus spiritus bovini vivum...... 865Vaccinum zonae vivum ................................................................. 828Vaginalia ........................................................................................... 738Valacicloviri hydrochloridum anhydricum............................ 3185Valerianae extractum aquosum siccum ..................................1259Valerianae extractum hydroalcoholicum siccum .................1260Valerianae radix ............................................................................1261Valerianae radix minutata..........................................................1262Valerianae tinctura .......................................................................1263Valinum ........................................................................................... 3188Valnemulini hydrochloridum ad usum veterinarium ......... 3188

Valsartanum ................................................................................... 3191Vancomycini hydrochloridum ................................................... 3192Vanillinum ...................................................................................... 3194Vaselinum album...........................................................................2670Vaselinum flavum .........................................................................2671Vecuronii bromidum .................................................................... 3195Vedaprofenum ad usum veterinarium .................................... 3196Venlafaxini hydrochloridum ...................................................... 3197Verapamili hydrochloridum ....................................................... 3198Verbasci flos.................................................................................... 1191Verbenae citriodoratae folium ................................................... 1166Verbenae herba ..............................................................................1264Via praeparandi stirpes homoeopathicas etpotentificandi...............................................................................1277

Vinblastini sulfas ...........................................................................3200Vincristini sulfas ...........................................................................3201Vindesini sulfas .............................................................................3202Vinorelbini tartras.........................................................................3204Vinpocetinum.................................................................................3206Violae herba cum flore ................................................................1266Vitamini synthetici densati A pulvis ........................................ 3211Vitaminum A ..................................................................................3208Vitaminum A syntheticum densatum oleosum .....................3209Vitaminum A syntheticum, solubilisatum densatum in aquadispergibile ...................................................................................3212

WWarfarinum natricum.................................................................. 3217Warfarinum natricum clathratum ............................................ 3218

XXanthani gummi ...........................................................................3237Xenoni (133Xe) solutio iniectabilis .............................................1023Xylazini hydrochloridum ad usum veterinarium ................3238Xylitolum .........................................................................................3239Xylometazolini hydrochloridum ...............................................3241Xylosum ...........................................................................................3242

YYohimbini hydrochloridum ........................................................3247

ZZidovudinum ..................................................................................3251Zinci acetas dihydricus ...............................................................3252Zinci acexamas ..............................................................................3253Zinci chloridum .............................................................................3254Zinci gluconas ...............................................................................3255Zinci oxidum ..................................................................................3255Zinci stearas ...................................................................................3256Zinci sulfas heptahydricus..........................................................3257Zinci sulfas hexahydricus ...........................................................3257Zinci sulfas monohydricus .........................................................3257Zinci undecylenas.........................................................................3258Zingiberis rhizoma ....................................................................... 1135Ziprasidoni hydrochloridum monohydricum .......................3258Zolpidemi tartras...........................................................................3260Zopiclonum.....................................................................................3261Zuclopenthixoli decanoas ...........................................................3263


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English and Latin Index 7th Edition 70

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