Category Monograph Title Monograph Section Scientific Liaison Revision <2> ORAL DRUG PRODUCTS-PRODUCT QUALITY TESTS PF 41(5) Pg. ONLINE INTRODUCTION Antonio Hernandez-Cardoso Revision <3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS - PRODUCT QUALITY TESTS PF 40(2) Pg. ONLINE INTRODUCTION, PRODUCT QUALITY TESTS FOR TOPICALLY APPLIEDTOPICAL AND TRANSDERMALDRUG PRODUCTS, SPECIFIC TESTS FOR OPHTHALMIC DRUG PRODUCTS, SPECIFIC TESTS FOR TOPICALLY APPLIED SEMISOLID DRUG PRODUCTS, SPECIFIC TESTS FOR TRANSDERMAL DELIVERY SYSTEMS, INTRODUCTION, PRODUCT QUALITY TESTS FOR TOPICAL AND TRANSDERMAL DRUG PRODUCTS, SPECIFIC TESTS FOR TDS Margareth Marques Revision <4> MUCOSAL DRUG PRODUCTS-PRODUCT QUALITY TESTS PF 41(5) Pg. ONLINE INTRODUCTION, PRODUCT QUALITY TESTS FOR MUCOSAL DRUG PRODUCTS William Brown Revision <5> INHALATION AND NASAL DRUG PRODUCTS GENERAL INFORMATION AND PRODUCT QUALITY TESTS PF 41(5) Pg. ONLINE 1. INTRODUCTION Kahkashan Zaidi Revision <121.1> PHYSICOCHEMICAL ANALYTICAL PROCEDURES FOR INSULINS PF 41(5) Pg. ONLINE INTRODUCTION/Introduction, INTRODUCTION/PEPTIDE MAPPING Mary Crivellone Revision <212> OLIGOSACCHARIDE ANALYSIS PF 41(5) Pg. ONLINE INTRODUCTION/Introduction, INTRODUCTION/ANALYTICAL PROCEDURES OVERVIEW, INTRODUCTION/SAMPLE PREPARATION, INTRODUCTION/SEPARATION AND IDENTIFICATION OF OLIGOSACCHARIDES, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>, ADDITIONAL REQUIREMENTS/APPENDIX Edith Chang Revision <341> ANTIMICROBIAL AGENTS--CONTENT PF 41(2) Pg. ONLINE Introduction, GENERAL GAS CHROMATOGRAPHIC METHOD, GENERAL GAS AND LIQUID CHROMATOGRAPHIC METHODS, POLAROGRAPHIC METHOD, USP REFERENCE STANDARDS <11> Shankari Shivaprasad Revision <771> OPTHALMIC PRODUCTS - QUALITY TESTS PF 41(5) Pg. ONLINE INTRODUCTION Margareth Marques New <782> VIBRATIONAL CIRCULAR DICHROISM SPECTROSCOPY PF 41(5) Pg. ONLINE 1. INTRODUCTION, 2. QUALIFICATION OF VCD SPECTROMETERS, 3. PROCEDURE, 4. VALIDATION, 5. VERIFICATION Kahkashan Zaidi Compendial Approvals for USP39-NF34 2S
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Category Monograph Title Monograph Section Scientific LiaisonRevision <2> ORAL DRUG PRODUCTS-PRODUCT QUALITY TESTS PF 41(5) Pg.
ONLINEINTRODUCTION
Antonio Hernandez-CardosoRevision <3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS - PRODUCT
QUALITY TESTS PF 40(2) Pg. ONLINEINTRODUCTION, PRODUCT QUALITY TESTS FOR TOPICALLY APPLIEDTOPICAL AND TRANSDERMALDRUG PRODUCTS, SPECIFIC TESTS FOR OPHTHALMIC DRUG PRODUCTS, SPECIFIC TESTS FOR TOPICALLY APPLIED SEMISOLID DRUG PRODUCTS, SPECIFIC TESTS FOR TRANSDERMAL DELIVERY SYSTEMS, INTRODUCTION, PRODUCT QUALITY TESTS FOR TOPICAL AND TRANSDERMAL DRUG PRODUCTS, SPECIFIC TESTS FOR TDS Margareth Marques
New <1004> MUCOSAL DRUG PRODUCTS-PERFORMANCE TESTS PF 41(5) Pg. ONLINE
INTRODUCTION, PERFORMANCE TESTS FOR MUCOSAL DRUG PRODUCTS, AEROSOLS AND NASAL SPRAYS, CREAMS, GELS, AND OINTMENTS, EMULSIONS, FILMS, GUMS, INSERTS, LOZENGES, SUPPOSITORIES, SUSUPENSIONS, SUBLINGUAL TABLETS AND BUCCAL TABLETS, REFERENCES William Brown
Revision <1029> GOOD DOCUMENTATION GUIDELINES PF 41(5) Pg. ONLINE INTRODUCTION, PRINCIPLES OF GOOD DOCUMENTATION, DATA COLLECTION AND RECORDING, DIFFERENT TYPES OF GMP DOCUMENTS Antonio Hernandez-Cardoso
New <1063> SHEAR CELL METHODOLOGY FOR POWDER FLOW TESTING PF 41(5) Pg. ONLINE
1. INTRODUCTION, 2. THEORY AND PRINCIPLES, 3. DESCRIPTION OF SHEAR CELL COMPONENTS AND DESIGNS, 4. SHEAR CELL MEASUREMENTS, 5. SELECTION OF TEST CONDITIONS, 6. TEST PROCEDURE, 7. DATA ANALYSIS AND CALCULATIONS, 8. REFERENCE MATERIALS AND REPRODUCIBILITY, 9. APPENDIX
Galina HollowayRevision <1130> NUCLEIC ACID-BASED TECHNIQUES -- APPROACHES FOR
INTRODUCTION, SAMPLE PRETREATMENT, QUANTITATIVE PCR-BASED RESIDUAL DNA ASSAY POLYMERASE CHAIN REACTION TECHNIQUES, PRACTICAL APPLICATIONS OF RESIDUAL DNA TESTING, RESIDUAL DNA TESTING POINTS TO CONSIDER
Dibyendu SahaNew <1228.3> DEPYROGENATION BY FILTRATION PF 41(5) Pg. ONLINE 1. INTRODUCTION, 2. TECHNOLOGIES USED FOR DEPYROGENATION
BY FILTRATION, 3. VALIDATION, 4. REFERENCES, 5. APPENDIXRadhakrishna Tirumalai
New <1228.5> ENDOTOXIN INDICATORS FOR DEPYROGENATION PF 41(5) Pg. ONLINE
1. INTRODUCTION, 2. ENDOTOXIN AND LPS, 3. APPLICATION OF ENDOTOXIN INDICATORS, 4. PREPARATION AND USE OF ENDOTOXIN INDICATORS, 5. ANALYSIS OF RESULTS OF DEPYROGENATION STUDIES, 6. REFERENCES Radhakrishna Tirumalai
New <1229.13> STERILIZATION-IN-PLACE PF 41(5) Pg. ONLINE INTRODUCTION, COMMON ELEMENTS OF STERILIZATION-IN-PLACE PROCESSES, CLOSED SYSTEMS, STERILIZATION-IN-PLACE METHODS, ROUTINE PROCESS CONTROL Radhakrishna Tirumalai
Revision <1231> WATER FOR PHARMACEUTICAL PURPOSES PF 41(5) Pg. ONLINE
INTRODUCTION, TABLE OF CONTENTS, 1. INTRODUCTION, 2. SOURCE WATER CONSIDERATIONS, 3. WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES, 4. VALIDATION AND QUALIFICATION OF WATER PURIFICATION, STORAGE, AND DISTRIBUTION SYSTEMS, 5. DESIGN AND OPERATION OF PURIFIED WATER AND WATER FOR INJECTION SYSTEMS, 6. SAMPLING, 7. CHEMICAL EVALUATIONS, 8. MICROBIAL EVALUATIONS, 9. ALERT AND ACTION LEVELS AND SPECIFICATIONS
Antonio Hernandez-CardosoNew <1782> VIBRATIONAL CIRCULAR DICHROISM SPECTROSCOPY –
THEORY AND PRACTICE PF 41(5) Pg. ONLINEIntroduction, 1. INTRODUCTION, 2. DEFINITION OF VIBRATIONAL CIRCULAR DICHROISM, 3. VCD INSTRUMENTATION, 4. MEASUREMENT OF VCD SPECTRA, 5. QUALITATIVE AND QUANTITATIVE ANALYSIS, 6. DETERMINATION OF ABSOLUTE CONFIGURATION, 7. CALCULATION OF VCD SPECTRA, 8. COMPARISON OF MEASURED AND CALCULATED SPECTRA, 9. DETERMINATION OF ENANTIOMERIC EXCESS, 10. CONCURRENT USE OF VCD FOR ABSOLUTE CONFIGURATION AND ENANTIOMERIC EXCESS, 11. REFERENCES
Kahkashan ZaidiRevision <2040> DISINTEGRATION AND DISSOLUTION OF DIETARY
SUPPLEMENTS PF 41(5) Pg. ONLINERUPTURE TEST FOR SOFT SHELL CAPSULES, DISSOLUTION
Natalia DavydovaRevision <2750> MANUFACTURING PRACTICES FOR DIETARY SUPPLEMENTS
PF 41(5) Pg. ONLINERAW MATERIALS, PRODUCT CONTAINERS, AND CLOSURES, RECORDS AND REPORTS Christopher Okunji
{Title} Compounded, DEFINITION/Introduction, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date Jeanne Sun
Revision AMITRAZ PF 41(2) Pg. ONLINE IDENTIFICATION/A. Infrared Absorption <197M><197>, IDENTIFICATION/B. Thin-Layer Chromatography, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination, Method I <921>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amitraz Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amitraz Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amitraz Related Compound C RS
Morgan PuderbaughRevision AMITRAZ CONCENTRATE FOR DIP PF 41(2) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure, SPECIFIC TESTS/Water
Determination, Method I <921> Morgan PuderbaughRevision AMLODIPINE ORAL SUSPENSION PF 40(5) Pg. ONLINE {Title} Compounded, DEFINITION/Introduction, ADDITIONAL
REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date Jeanne Sun
Revision ANTITHROMBIN III HUMAN PF 41(5) Pg. ONLINE Chemical Info, DEFINITION/Introduction, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Molecular Weight Distribution, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albumin Human RS Kevin Carrick
Revision ARIPIPRAZOLE PF 41(2) Pg. ONLINE IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731> Heather Joyce
{Title} Compounded, DEFINITION/Introduction, ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date Jeanne Sun
Revision GUAIFENESIN PF 41(5) Pg. ONLINE IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/C., SPECIFIC TESTS/Melting Range or Temperature <741> Clydewyn Anthony
REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling Jeanne Sun
Revision INSULIN INJECTION PF 41(5) Pg. ONLINE DEFINITION/Introduction, ASSAY/Procedure, Limit of High Molecular Weight Proteins, Physicochemical Analytical Procedures for Insulins <121.1>, Limit of High Molecular Weight Proteins, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Insulin RS Manoj Metta
Revision ISOPHANE INSULIN SUSPENSION PF 41(5) Pg. ONLINE ASSAY/Procedure, Limit of High Molecular Weight Proteins, Physicochemical Analytical Procedures for Insulins <121.1>, Limit of High Molecular Weight Proteins Mary Crivellone
Revision INSULIN ZINC SUSPENSION PF 41(5) Pg. ONLINE ASSAY/Procedure, Limit of High Molecular Weight Proteins, Physicochemical Analytical Procedures for Insulins <121.1>, Limit of High Molecular Weight Proteins Mary Crivellone
Revision EXTENDED INSULIN ZINC SUSPENSION PF 41(5) Pg. ONLINE ASSAY/Procedure, Limit of High Molecular Weight Proteins, Physicochemical Analytical Procedures for Insulins <121.1>, Limit of High Molecular Weight Proteins Mary Crivellone
Revision PROMPT INSULIN ZINC SUSPENSION PF 41(5) Pg. ONLINE ASSAY/Procedure, Limit of High Molecular Weight Proteins, Physicochemical Analytical Procedures for Insulins <121.1>, Limit of High Molecular Weight Proteins Mary Crivellone
Morgan PuderbaughRevision NARATRIPTAN HYDROCHLORIDE ORAL SUSPENSION PF 40(6) Pg.
ONLINE{Title} Compounded, DEFINITION/Introduction, ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date Jeanne Sun
New 2 N NITRIC ACID TS PF 41(5) Pg. ONLINE 2 N Nitric Acid TS Margareth MarquesNew 0.2 N NITRIC ACID TS PF 41(5) Pg. ONLINE 0.2 N Nitric Acid TS- Margareth MarquesNew 0.01 N NITRIC ACID TS PF 41(5) Pg. ONLINE 0.01 N Nitric Acid TS Margareth MarquesNew 1 N NITRIC ACID TS PF 41(5) Pg. ONLINE 1 N Nitric Acid TS Margareth MarquesNew NORTHERN SCHISANDRA FRUIT DRY EXTRACT PF 41(4) Pg. ONLINE DEFINITION/Introduction, IDENTIFICATION/A. Thin-Layer
Chromatography, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Lignans, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test Procedures, Test for Absence of Escherichia coli, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Total Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Schisandra chinensis Fruit Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Schisandrin RS
Revision PYRAZINAMIDE ORAL SUSPENSION PF 40(6) Pg. ONLINE {Title} Compounded, DEFINITION/Introduction, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date Jeanne Sun
Revision PYRIMETHAMINE ORAL SUSPENSION PF 41(1) Pg. ONLINE {Title} Compounded, DEFINITION/Introduction, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date Jeanne Sun
Revision QUINIDINE SULFATE ORAL SUSPENSION PF 41(1) Pg. ONLINE {Title} Compounded, DEFINITION/Introduction, ADDITIONAL REQUIREMENTS/Beyond-Use Date Jeanne Sun
Revision POWDERED RED CLOVER EXTRACT PF 41(5) Pg. ONLINE IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPTLC for Articles of Botanical Origin <203>, COMPOSITION/Content of Isoflavones, CONTAMINANTS/Microbial Enumeration Tests <2021> Anton Bzhelyansky
ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropinirole Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropinirole Related Compound B RS
K. SeelaRevision POWDERED ST. JOHN'S WORT EXTRACT PF 41(5) Pg. ONLINE DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of
Botanical Origin <203>, COMPOSITION/Content of Hypericin and Pseudohypericin, COMPOSITION/Content of Hyperforin, CONTAMINANTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Residual Solvents, SPECIFIC TESTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Residue on Evaporation, SPECIFIC TESTS/Other Requirements Anton Bzhelyansky
Revision SCHIZOCHYTRIUM OIL PF 41(5) Pg. ONLINE DEFINITION/Introduction, IDENTIFICATION/A. Long Chain Unsaturated Fatty Acid Profile, COMPOSITION/Content of DHA and EPA, ADDITIONAL REQUIREMENTS/Labeling Huy Dinh
Revision SHELLAC PF 40(4) Pg. ONLINE Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B. Identification of Aleuritic Acid and Shellolic Acid by Thin-Layer Chromatography, IMPURITIES/Limit of Chloride, IMPURITIES/Total Ash, IMPURITIES/Ethanol-Insoluble Substances, SPECIFIC TESTS/Acid Value, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Hong Wang
{Title} Compounded, DEFINITION/Introduction, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling Jeanne Sun
Revision THEOPHYLLINE PF 41(3) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Acidity, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Caffeine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Theophylline Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Theophylline Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Theophylline Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Theophylline Related Compound F RS
Ren-Hwa YehRevision THEOPHYLLINE ORAL SUSPENSION PF 41(1) Pg. ONLINE {Title} Compounded, DEFINITION/Introduction Jeanne SunRevision THIOTEPA FOR INJECTION PF 41(4) Pg. ONLINE SPECIFIC TESTS/Completeness of Solution <641>, SPECIFIC
TESTS/Injections and Implanted Drug Products <1>, Product Quality Tests Common to Parenteral Dosage Forms, Specific Tests, Completeness and clarity of solutions Feiwen Mao
{Title} Compounded, DEFINITION/Introduction, ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date Jeanne Sun
ONLINE{Title} Compounded, DEFINITION/Introduction, ADDITIONAL REQUIREMENTS/Beyond-Use Date Jeanne Sun
Revision VINBLASTINE SULFATE FOR INJECTION PF 41(4) Pg. ONLINE IDENTIFICATION/B., IDENTIFICATION/B, SPECIFIC TESTS/Constituted Solution, SPECIFIC TESTS/Injections and Implanted Drug Products <1>, Product Quality Tests Common to Parenteral Dosage Forms, Specific Tests, Completeness and clarity of solutions, SPECIFIC TESTS/Completeness of Solution <641>
