QC for Parenterals-wb

7/29/2019 QC for Parenterals-wb

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Sudheerkumar kamarapuAssist professor

sri shivani college of pharmacy

Warangal, A.P

VINAY V. KUMAR



LVPs

Large-volume intravenous solution: is a single doseinjection that is intended for iv use and is packaged in

container labeled as containing more than 100 ml

SVPs

Small-volume intravenous injection: is applied to an

injection that is packaged in containers labeled as

containing 100 ml or less.

Parenteral articles are preparations intended for injection

through the skin or other external boundary tissue, rather than through the alimentary canal.

What are parenterals ?



Injections:

Sterile,

Pyrogen free preparations intended to be administered parenterally (outside alimentary tract).

Why Parenterals?

1) Rapid action2) Oral route can not be used3) Not effective except as injection

4) Many new drugs particularly those derived from newdevelopment in biotechnologically can only be given by parenteral coz they are inactivated in GIT if given orally.5) New drugs require to maintain potency & specificity so

that they are given by parenteral.



Advantages:

Quick onset of action

Suitable for the drugs which

are not administered by oral

route

Useful for unconscious or

vomiting patients.

Duration of action can be

prolonged by modifying

formulation.

Suitable for nutritive like

glucose & electrolyte.

Suitable for the drugs which

are inactivated in GIT or HCl

(GI fluid)

Disadvantages: Once injected cannot be

controlled (retreat)Injections may cause pain at

the site of injectionOnly trained person is required

If given by wrong route,difficult to control adverseeffectDifficult to save patient if

overdose

Sensitivity or allergic reactionat the site of injectionRequires strict control of

sterility & non pyrogenicity

than other formulation.

Advantages Vs Disadvantages



Requirements for Parenteral preparations:

Sterility (must)

Pyrogen (must)

Free from particulate matter (must)

Stability (must)

Isotonicity (should)

Solvents or vehicles used must meet purity and other standards.

Restrictions on buffers, stabilizers, antimicrobial preservative.

Do not use coloring agents.

Must be prepared under aseptic conditions.

Specific and high quality packaging.



Routes of Parenteral Administration

IntradermalIntramuscular

IntravenousSubcutaneous

Dermis

Intra-arterial

Vein

Artery

Muscle

Epidermis

Subcutaneous

tissue



Official Types of Injections:

Solutions : Example: Codeine Phosphate Injection

Dry solids or liquid concentrate does not contain diluents

etc.

Example: Sterile Ampicillin Sodium

If diluents present, referred to as.....for injection

Example: Methicillin Sodium for injection Suspensions

"Sterile....Suspension"Example: Sterile Dexamethasone Acetate Suspension

Dry solids: which upon the addition of suitable vehicles yield preparations containing in all respects to the requirements for sterile suspensions.Title: Sterile....for SuspensionExample: Sterile Ampicillin for Suspension

Injectable Emulsions:



Formulation of Parenterals

1. Therapeutic agents2. Vehicles

i. Water ii. Water miscible vehiclesiii.Non- aqueous vehicles

3. Added substances (Additives)

i. Antimicrobialsii. Antioxidantsiii.Buffersiv.Bulking agentsv. Chelating agents

vi.Protectantsvii.Solubilizing agentsviii.Surfactantsix.Tonicity- adjusting agents



1. Cleaning

2. Preparation of bulk products

3. Filtration

4. Filling of solution in or product in ampoule or vial

7. Tests for Quality control

5.Sealing

6. Sterilization

General steps in Manufacturing of parenterals



Production facilities:

Clean- up area

Preparation area

Aseptic area

Quarantine area

Finishing and packaging area

ST

O

C

K

R

O

O

M

COMPOUNDING

AREA

CLEAN UP

AREA

ASEPTIC

AREA

QUARANTINE

AREA

STERILIZATION

STORAGE

AND

TRANSPORTPACKING

AND

LABELLING



Important Aqueous VehiclesPurified water : Do not use for Parenterals

Sterile Purified water : Do not use for Parenterals

Sterile water for inhalation: Do not use for Parenterals Sterile water for Irrigation: Do not use for Parenterals

Sterile water for injection:

It is prepared from water for injection that is sterilized and suitably

packaged. It contains no antimicrobial agent. It is used as diluents

for parenteral products.

It is packaged in single dose container not larger than 1-Litre size.

Bacterial Endotoxin Test + Particulate Matter Test.

Bacteriostatic water for Injection:

It contains on or more suitable antimicrobial agents. It is intended to be used as diluent for parenteral products.

packaged in single or multiple-dose containers, not larger than 30

mL

NOT FOR USE IN NEWBORNS-



Particulate matter in injections and parenteral infusionsconsists of mobile undissolved particles, other than gasbubbles, unintentionally present in the solutions.

For the determination of particulate matter, two procedures,

Method 1 (Light Obscuration Particle Count Test)

Method 2 (Microscopic Particle Count Test)

When examining injections and parenteral infusions for sub-visible particles Method 1 is preferably applied.However, it may be necessary to test some preparations bythe light obscuration particle count test followed by themicroscopic particle count test to reach a conclusion onconformance to the requirements.

PARTICULATE MATTER IN INJECTIONS



• When Method 1 is not applicable, e.g. in case of

preparations having reduced clarity or increased viscosity,

the test should be carried out according to Method 2,

Emulsions, colloids, and liposomal preparations are

examples.

• Similarly, products that produce air or gas bubbles when

drawn into the sensor may also require microscopic particlecount testing.

• If the viscosity of the preparation to be tested is sufficiently

high so as to preclude its examination by either test

method, a quantitative dilution with an appropriate diluentsmay be made to decrease viscosity, as necessary, to allow

the analysis to be performed.



METHOD 1. LIGHT OBSCURATION PARTICLE COUNT TEST

Use a suitable apparatus based on the principle of light blockage

which allows an automatic determination of the size of particles and

the number of particles according to size.

General precautions

The test is carried out under conditions limiting particulate matter,

preferably in a laminar-flow cabinet.

Very carefully wash the glassware and filtration equipment used,with a warm detergent solution and rinse with abundant amounts of

water to remove all traces of detergent. Immediately before use, rinse

the equipment from top to bottom, outside and then inside, with

particle-free water.Take care not to introduce air bubbles into the preparation to be

examined, especially when fractions of the preparation are being

transferred to the container in which the determination is to be

carried out.



Method

Mix the contents of the sample by slowly inverting the container 20

times successively. If necessary, cautiously remove the sealing closure.

Clean the outer surfaces of the container opening using a jet of particle-free water and remove the closure, avoiding any contamination of the

contents. Eliminate gas bubbles by appropriate measures such as

allowing to stand for 2 min or sonicating.

For large-volume parenterals, single units are tested.For small-volume parenterals less than 25 ml in volume, the contents

of 10 or more units is combined in a cleaned container to obtain a

volume of not less than 25 ml;

the test solution may be prepared by mixing the contents of a suitable

number of vials and diluting to 25 ml with particle-free water or withan appropriate particle-free solvent when particle-free water is not

suitable.

Small volume parenterals having a volume of 25 ml or more may be

tested individually.



Remove four portions, each of not less than 5 ml, and count the

number of particles equal to or greater than 10 μm and 25 μm.

Disregard the result obtained for the first portion, and calculate the

mean number of particles for the preparation to be examined.

Acceptance Criteria:For preparations supplied in containers with a nominal volume of more

than 100 ml: The preparation complies with the test if the average

number of particles present in the units

Size I.P (per mL) USP (per mL)

≥ 10 µm NMT 25 NMT 50

≥ 25 µm NMT 3 NMT 5For preparations supplied in containers with a nominal volume of less

than 100 ml : The preparation complies with the test if the averagenumber of particles present in the units

Size I.P (per container) USP(per

container)

≥ 10 µm NMT 6000 NMT 10000



METHOD 2. MICROSCOPIC PARTICLE COUNT TEST

The microscope is equipped with an ocular micrometer calibrated with

an objective micrometer, a mechanical stage capable of holding and

traversing the entire filtration area of the membrane filter, and is adjusted

to 100 ± 10 magnifications.

If the average number of particles exceeds the limits, test the

preparation by the Microscopic Particle Count Test.



Visual method:Simple method

Filled container are examined against strong illuminated screen by

holding neck & rotating it slowly or inverted it to keep out the foreignmatter.

Coulter counter method:It is used for detection of particles less than 0.1 micrometer in

diameter.

Based on electrode resistance.

Sample is evaluated between two electrode & if particle found the

resistance of electrode is increased.



PYROGEN TEST

Pyrogens :

Pyrogenic - means producing fever Pyrogens - fever inducingsubstances

Having nature Endogenous (inside body) Exogenous (outside body)

Exogenous pyrogens – mainly lipopolysaccharides bacterial origin,

but not necessary

Produced mostly by gram-negative bacteria

Endotoxin - complex of pyrogenic lipopolysaccharide, a

protein and inert lipid;

lipid part of the lipopolysaccharide is the main pyrogenic agent;

polysaccharide part increases solubility

Endotoxin:



solvent - possibly the most important source

the medicament

the apparatus

the method of storage between preparation and sterilization

Characteristicsthermostable

water-soluble

unaffected by the common bactericides

non-volatileThese are the reasons why pyrogens are difficult to

destroy once produced in a product

Sources of pyrogen contamination



I Love The

Rabbit!

OFFICIAL TESTS FOR PYROGEN

To check the presence or absence of pyrogens in parenterals.

The Pyrogen Test (using Rabbit)Bacterial Endotoxin or The Limulus Amebocyte Lysate

(LAL) Test

The Pyrogen Test (using Rabbit)

• The test involves the measurement of rise in body temperature of rabbits

following intravenous injection of a

sterile solution of a parental

preparation being examined• Rabbits are used for this test because

their body temperature increases when

pyrogens are introduced into their

bodies through parental route



Selection:Rabbits must be healthy and mature New Zealand or Belgian Whites used

Either sex may be usedLength of use >48 hours within negative result >2 weeks within a positive result

Must be individually housed between 20 and 23°CPreliminary test (Sham Test)intravenous injection of sterile pyrogen-free saline solution

to exclude any animal showing an unusual response to the

trauma (shock) of injection

any animal showing a temperature variation greater than

0.6C is not used in the main test

Use temperature-sensing probe to measure the rabbit’s body

temp. 30 min before the injection of the test dose. (use threerabbits .

M i t t



Main test:

group of 3 rabbits

preparation and injection of the product:

warming the product dissolving or dilution

duration of injection: not more than 4 min

the injected volume: not less than 0.5 ml per 1 kg and

not more than 10 ml per kg of body massdetermination of the initial and maximum temperature

all rabbits should have initial T: from 38.0 to 39.8C

the differences in initial T should not differ from one

another by more than 1C

Record the temp. at 30-min intervals between 1 and 3

hours subsequent to the injection.

Insert the temperature-sensing probe into the rectum of the test rabbit to

a depth of not less than 7.5 cm, and, record the rabbit's body temperature.



Acceptance criteria: (USP)Consider any temperature decreases as zero rise.

If no rabbit shows an individual rise in temperature of

0.5° or more above its respective control temperature,

the product meets the requirements for the absence of

pyrogens.

If any rabbit shows an individual temperature rise of

0.5° or more, continue the test using five other rabbits.

If not more than three of the eight rabbits show

individual rises in temperature of 0.5° or more and if

the sum of the eight individual maximum temperaturerises does not exceed 3.3°, the material under

examination meets the requirements for the absence of

pyrogens.

LAL TEST



LAL TEST

to detect or quantify endotoxins of

gram-negative bacterial origin

reagent: amoebocyte lysate fromhorseshoe crab ( Limulus polyphemus or

Tachypleus tridentatus).

The name of the test is also Limulus

amebocyte lysate (LAL) test

the test is based on the primitive blood-clotting mechanism of the

horseshoe crab

METHOD

avoid endotoxin contamination before the test:

equal V of LAL reagent and test solution (usually 0.1 ml of each)are mixed in a depyrogenated test-tube

incubation at 37°C, 1 hour

remove the tube - invert in one smooth motion (180°) - read

(observe) the result ass-fail test

LAL TEST (C td )



Three different techniques:

the gel-clot technique - gel formation

the turbidimetric technique - the development of turbidity

after cleavage of an endogenous substrate the chromogenic technique - the development of color after

cleavage of a synthetic peptide-chromogen complex

• 6 methods with different steps of accuracy of LAL test

results:

– Method A: gel-clot method: limit test

– Method B: gel-clot method: semi-quantitative test

– Method C: turbidimetric kinetic method – Method D: chromogenic kinetic method

– Method E: chromogenic end-point method

– Method F: turbidimetric end-point method

• In the event of doubt or dis ute the final decision is made

LAL TEST (Contd..)

GEL CLOT METHOD



GEL-CLOT METHOD

1. Limit test (method A) A firm gel - positive result. an intact gel is not formed - negative result.

2. Semi-quantitative test (method B)Quantification of bacterial endotoxins in the test solution by

titration to an end-point.The results are expressed as concentration of endotoxin as

less, equal or greater than (labeled lysate sensitivity)

TURBIDIMETRIC METHOD1. Kinetic method (method C)Used to measure either time required for the reaction mixture

to reach a predetermined absorbance, or the rate of turbiditydevelopment

2. Endpoint method (method F)Based on the quantitave relationship between the endotoxin

concentration and turbidity of reaction mixture at the end of

an incubation time.

CHROMOGENIC METHOD



CHROMOGENIC METHODThis tec hnique is used to measure the chromophore released from a

suitable chromogenic peptide by the reaction of endotoxins with the

lysate.

The kinetic-chromogenic test (Method D) measures either the time

(onset time) needed for the reaction mixture to reach a predetermined

absorbance, or the rate of colour development.

The end-point-chromogenic test (Method E) is based on the

quantitative relationship between the endotoxin concentration and thequantity of chromophore released at the end of an incubation period.

Route of administration K (IU of endotoxin per kilogram

of body mass per hour)

Intravenous 5.0

Intravenous

(Radiopharmaceuticals)

2.5

Intrathecal 0.2



STERILITY TESTING

Sterility testing attempts to reveal the presence or absence of viable

micro-organisms in a sample number of containers taken from batch

of product. Based on results obtained from testing the sample adecision is made as to the sterility of the batch.

is made after the product exposition to the one of the possible

sterilization procedures

can only provide partial answers to the state of sterility of the product batch under test

is inadequate as an assurance of sterility for a terminally sterilized

product

Factors important in sterility testing

The environment in which the test is conducted

The quality of the culture conditions provided

The test method

The sample size

The sampling procedure



Environment al Conditions

• avoid accidental contamination of the product during the test

• the test is carried out under aseptic conditions

• regular microbiological monitoring should be carried out

Culture conditions

Appropriate conditions for the growth of any surviving organism

should be provided by the culture media selection

• Factors affecting growth of bacteria (Nutrition, pH, temperature..etc)

• Phases of bacterial growth• Culture media for sterility testing

capable of initiating and maintaining the vigorous growth of a

small number of organisms

sterile Types of media:

1. Fluid thioglycollate medium

2. Soya-bean casein digest medium

3. other media



Fluid thioglycollate medium primarily intended for the

culture of anaerobic bacteria

incubation of the media: 14

days at 30 -35°C

Soya-bean casein digest medium

primarily intended for the culture

of both fungi and aerobic bacteria

incubation of the media: 14 days

at 20 -25°C

STERILITY TESTING METHODS



STERILITY TESTING METHODS1. Membrane Filtration

2. Direct inoculation

Membrane FiltrationAppropriate for :

filterable aqueous preparations

alcoholic preparations

oily preparations

preparations miscible with or soluble in aqueous or oily

solutions to be examined must be introduced and filtered under aseptic

conditions

All steps of this procedure are performed aseptically in a Class 100

Laminar Flow HoodSelection:

• pore size of 0.45 m

• effectiveness established in the retention of micro-organisms

•

appropriate composition• the size of filter discs is about 50 mm in diameter

Solutions: Direct filtration



Solutions: Direct filtration

Suspensions: Add sufficient quantity

of diluents for rapid filtration.

Oils and oily solutions: if less viscous

then directly filter and if more viscousthen dilute with proper diluents.

Ointments and creams: prepare

1%w/v with suitable diluents with the

help of heat if required but NMT 40˚C. Sterile Devices: take the sample and

shake it for 10 min with 50 ml of

suitable broth then instantly pass the

mixture through membrane filter which

is previously moisten with liquid.

Membrane is wash with broth 50 ml

for 3-4 times and incubates the test

media.

There are some special procedure for surgical cotton, and suture/ligatureetc.

Direct inoculation



Direct inoculation

suitable quantity of the

preparation to be

examined is transferreddirectly into the

appropriate culture

medium

volume of the product isnot more than 10% of the

volume of the medium

suitable method for

aqueous solutions, oily

liquids, ointments ancreams

Advantages of membrane filtration method



Advantages of membrane filtration method wide applications

a large volume can be tested with one filter

smaller volume of culture media is required

applicable to substances for which no satisfactory inactivators

are known

neutralization is possible on the filter

subculturing is often eliminated

shorter time of incubation compared with direct inoculation

Parameter I.P USP EP

Incubation

time (days)

7* 7 * 7*

Incubationtemperature

30-35 ⁰C(bacteria)20-25 ⁰C

(fungi)

30-35 ⁰C(bacteria)20-25 ⁰C

(fungi)

30-33⁰ C(bacteria)20-25 ⁰C (fungi)

* For steam and membrane sterilization but atleast14 days for others

Interpretation of results



Interpretation of results

If no growth or contamination batch passes test.

If growth observed and authority will permit to repeat the test then

repeat test with greater care.

If again growth observed in repeat test, authority will allowrepeating unless same microorganism is observe in the two tubes.

Generally, one repeat test is allowed for bulk sample and two repeat

tests are allowed for final container sample according to WHO.

If 2 or more/3 or more and any growth observed in 1

st

, 2nd

, 3rd

test respectively then batch will considered an unsuitable (fails sterility

test).

Product flush:

The product flush sterility test is reserved for products that havehollow tubes, such as transfusion and infusion assemblies, where

immersion is impractical and where the fluid pathway is labeled as

sterile.

The products are flushed with fluid and the eluate is membrane filtered

and placed into FTM and SCDM. This method is not generally used.

Sampling for sterility testing (I P)



Sampling for sterility testing (I.P)

Quantities of Liquids/Solids per Container of Injectables Vs



Quantities of Liquids/Solids per Container of Injectables VsMinimum Quantitiy - Recommended for Each Culture Medium.Type prep. Qty. in Each Container Min. Qty.Recommended

for Each Culture Medium

Liquids (a) Less than 1 mL Total contents of a container

(b) 1 mL or more but < 4 mL Half the contents of container

(c) 4 mL or more but < 20 mL 2 mL

(d) 20 mL or more but < 100 mL 10% of the contents of container

unless otherwise specified duly in

the ‘monograph’.

(e) 100 mL or more Not less than half the contents of

container unless otherwisespecified in the ‘monograph’.

Solids (a) Less than 50 mg Total contents of a container.

(b) 50 mg or more but < 200 mg Half the contents of a container.

c 200 m or more 100 m .

O hth l i S l ti



Ophthalmic Solutions :

Other non-injectable

liquid preparations. 10 — 100 mL 5 — 10 mL

2 Other Preparations :Preparations soluble in water

or appropriate solvents ;

insoluble preparations

to be suspended or emulsified

duly (e.g., creams and

ointments). 1 — 10 g 0.5 — 1 g

3 Absorbent cotton Not less than 1 g*

USP Official Requirement

Batch Size Sample Size Normal Lots > 1000 40 Articles

< 100 0% or 8 (whichever is greater)

100-500 20 Articles

500-1000 4% or 40 (whichever is less)

LEAKAGE TEST FOR SVP



This test is performed only for ampoules which have been sealed

by fusion to ensure that there should not be any leakage in them. Ampoules are dipped in 1% methylene blue soln.

It is performed in vaccum chamber.

Vials & bottles not subjected to this test because of flexibility of

rubber.

LEAKAGE TEST FOR SVPs



Packaging The container is made of material that permits

inspection of the contents. Containers are closed by fusion or by application of suitable

closures.

Elastomeric closures for Injections are made of materials

obtained by vulcanization (cross-linking) or polymerization of macromolecular organic substances (elastomers).

Closure formulations contain natural or synthetic elastomers

and inorganic and organic additives to aid or control

vulcanization, impart physical and chemical properties or color, or stabilize the closure formulation.

Such closure are typically used as part of a vial,

bottle, or pre-fill syringe package system.

http://yortix.com/Catalog.htm



Criteria for the selection of an elastomeric closure should also

include a careful review of all the ingredients to assure that no known

or suspected carcinogens, or other toxic substances are added.

Functionality tests

Includes: penetrability, fragmentation, self-sealing capacityFunctionality tests are performed on closures intended to be pierced

by a hypodermic needle.

The self-sealing capacity is required only for closures intended for

multiple-dose containers.

The needle specified for each test is a lubricated long bevelhypodermic needle*.

* Sterile hypodermic needle with an external diameter of 0.8mm (21

Gauge).

Penetrability



Penetrability

Procedure — Fill 10 suitable vials to the nominal volume with water, fit

the closures to be examined, and secure with a cap. Using a new

hypodermic needle for each closure, pierce the closure with the needle

perpendicular to the surface. Requirement — The force for piercing is no greater than 10 N (1 kgf) for

each closure, determined with an accuracy of ± 0.25 N (25 gf).

Fragmentation

Closures for Liquid Preparations —

Fill 12 clean vials with water to 4 mLless than the nominal capacity. Fit the closures to be examined, secure

with a cap, and allow to stand for 16 hours.

Closures for Dry Preparations — Fit closures to be examined into 12

clean vials, and secure each with a cap.

Procedure —

Using a hypodermic needle fitted to a clean syringe, inject

into each vial 1 mL of water while removing 1 mL of air. Repeat this

procedure 4 times for each closure, piercing each time at a different site.

Use a new needle for each closure, checking that it is not blunted during

the test.

Filter the total volume of liquid in all the vials through a single



Filter the total volume of liquid in all the vials through a single

filter with a nominal pore size no greater than 0.5 µm.

Count the rubber fragments on the surface of the filter visible

to the naked eye.Requirement:

there are no more than 5 fragments visible.

This limit is based on the assumption that fragments with a

diameter ≻ 0.5 µm are visible to the naked eye. In case of doubt, the particles are examined microscopically to

verify the nature and size.

Self-Sealing Capacity

Procedure—

Fill 10 suitable vials with water to the nominalvolume. Fit the closures that are to be examined, and cap.

Using a new hypodermic needle as described above for each

closure, pierce each closure 10 times, piercing each time at a

different site.

I h 10 i l i l i f 0 1% (1 L) h l



Immerse the 10 vials in a solution of 0.1% (1 g per L) methylene

blue, and reduce the external pressure by 27 kPa for 10 minutes.

Restore to atmospheric pressure, and leave the vials immersed for

30 minutes. Rinse the outside of the vials. Requirement —None of the vials contain any trace of blue solution.

Type of glass containers:

Type I, II: Soda-lime glass is suitably dealkalized are usually

used for packaging neutral and acidic parenteral

preparations.

Type III is soda-lime glass containers are not used forparenteral preparations.

Type NP glass: for packaging nonparenteral articles, for oral

and topical use.

Po dered glass Test



Powdered glass Test:

Use crushed glass containers in 250-ml conicalflask, add 50 ml high purity water, cap the flask with

borosilicate glass beaker Place the containers in the autoclave and close it

securely hold temperature at 121±2C for 30 min.,counting from the time this temperature is reached.

cool the flask, decant the water from the flask into aclean vessel, and wash the residual powdered glasswith high purity water, add 5 drops methyl redsolution, titrate immediately with 0.02 N sulfuric acid

. Record the volume of 0.02N Sulfuric acid used to

neutralize the extract from 10 g of the preparedspecimen of glass.

W t tt k t 121°C



Water attack at 121°C

Rinse 3 or more containers with high purity water

Fill each container to 90% of its capacity with high purity

water Cap all the flasks with borosilicate glass beaker, place in the

autoclave at 121 C for 60 minmL of 0.02 N

acid

General

description

Type

1.0High resistant

borosilicate glass

I

0.7

0.2

Treated soda lime

glass

II

8.5

Soda lime glassIII

15.0

All purpose glassNP

Labels and labeling



Labels and labeling

The label states the name of the preparation

The percentage content of drug in a specified volume

The route of administration

Storage condition

Expiration date

Name of the manufacturer

The lot number

Containers for injection that are intended for use as dialysis, orirrigation solution are labeled to indicate that the contents are notintended for use by iv infusion

Injection intended for veterinary use are labeled to that effect The containers are so labeled that a sufficient area of the container

remains uncovered for its full length to permit inspection of thecontents

In process QC tests for Parenterals



In-process QC tests for Parenterals

o Sterility

o Pyrogen

o Free from particulate matter

o Stability

o Isotonicity

QUALITY CONTROL OF OINTMENTS AND CREAMS



QUALITY CONTROL OF OINTMENTS AND CREAMS

Uniformity of mass

Weigh individually the contents of 20 containers, then completely

empty the containers and determine the average mass. Not more than

2 of the individual masses deviate by more than 10 per cent from

the average mass and none deviate by more than 20 per cent.

Sterility Testing: As described in Parenterals

Storage: Well-closed container and temperature more than 30 C. Do

not freeze

Labelling:

Concentration of antimicrobial preservative

Storage conditions

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