FPQC Cream

QC TESTS FOR CREAMS:
1- Physical appearance:
Following characteristics must be evaluated for physical appearance of ointments and creams;
Cracking of emulsion (separation of oil and water phase) Development of granular or lumpy
appearance Marked changes in viscosity Crystal growth Gross microbial contamination
2- Particle size determination:
Dilute suitable amount of the preparation with equal amount of glycerol or liquid paraffin (as
specified in monograph). Mount the mixture on the slide and examine under high resolving
power microscope. Count the number of particles with diameter above or below than the
specified limit in the monograph. Compare the percentage with the official limits.
3- Weight Variation Test:
Select the 10 filled containers Remove any label that could lead to weight variation Cleanse the
outer thoroughly, dry and weigh each unit individually Cut the lateral part of containers,
remove their contents by washing, dry them and weigh each unit along with its corresponding
parts Difference between the weights give the weight of the content. Calculate the average
weight of the contents.
SPECIFICATIONS The average net weight of the content should not be less than the labelled
amount. The net weight of the contents of any single container should not be less than 90% of
the labelled amount (for 60g or less) and not less than 95% of the labelled amount (for more
than 60g but not more than 150g). If the requirements are not met, weigh the contents of 20
additional containers. Average net weight of the contents of 30 containers must not be less
than the labelled amount. Contents of not more than 1 out of 30 containers should be less than
90% of the labelled amount (for 60g or less) and not less than 95% of the labelled amount (for
more than 60g but not more than 150g).
4- Solubility test:
The contents should be soluble in 9parts of water and in 1.7 parts of hot water. The contents
should be miscible with alcohol, ether and chloroform. Viscosity shall be determined as
specified in the individual monograph. 5- Viscosity determination
Assay of active contents Assay of active contents should be performed according to official
monograph and percentage should be within the official limits. 7- Sterility test for ophthalmic
ointments This shall be performed according to the official monograph by any of the following
method specified ; 1- Membrane filtration method 2- Direct inoculation method
1- Visual examination (organoleptic properties)
2- Average filling weight
3- Content uniformity
4- Homogeneity
5- Rheological studies
6- Spreadability
7- Determination of pH
8- Microbial content
9- In-vitro drug release
10- Accelerated stability studies
1- Visual examination (Organoleptic properties)
The color, odor and other physical characteristics of the product are noted by visual
examination.
2- Average filling weight
In this test, the net weight or volume of the contents of the filled containers is
determined. It is carried out to ensure that the product contains the proper content
when compared with the labeled amount.
Weigh the intact container at the beginning of the analysis. After the analysis is
completed, remove any remaining sample and weigh the empty container. Calculate the
weight of the product by difference.
3- Content uniformity
Assay of the active ingredients must be carried out to ensure that the semisolid product
contain the labeled amount of the drug.
4- Homogeneity
Test for homogeneity of semisolid preparations is done to assure the absence of gritty
particles in the preparation upon its application to the skin.
5- Rheological studies
The viscosity of the semisolid preparation is measured using a Brookfield viscometer.
6- Spreadability
Spreadability is the degree of spreading of the semisolid preparation upon its application
to the skin. A sample of 1 g of semisolid was placed at the center of the glass plate (10 x
10 cm) ad another glass plate was placed over it carefully above the glass plates 2
kilogram weight was placed at the center of the plate avoid sliding of the plate. The diameter of
the semisolid in centimeters was measured after 30 minutes. The experiment was repeated
three times and the average was calculated.
7- pH determination
pH of the semisolid preparation should be measured to avoid irritation upon its
application to the skin. One gm of the preparation is mixed with 9 ml of distilled water
and the pH of the resulting mixture is determined using a glass electrode instrument (pH
meter).
8- Microbial content
Semisolid preparations containing water tend to support microbial growth to a greater
extent than water-free preparations. Therefore, those preparations should be examined
for P. aeruginosa and S. aureus. Preparations intended for rectal, vaginal or urethral use
should be tested for yeasts and molds which are common offenders at these sites of
application.
8- In-vitro drug release
A dialysis membrane is loaded with 2 g of the medicated semisolid, suspended in a
beaker containing 100 ml of dissolution medium of pH 6.8, maintained at a temperature
of 32ºC and stirred at 100 rpm for one hour. Samples of the dissolution medium are
withdrawn at time intervals to determine the amount of the drug in solution. The
release results are plotted as concentration versus time.
9- Accelerated stability studies
It is based on stressing the system, either by temperature or centrifugation.
a- Effect of centrifugation
Centrifugation can be used to predict long-term behavior of semisolids. Centrifugation at
3750 rpm for 5 hours is equivalent to the effect of gravity for one year.
b- Effect of freeze-thaw cycling
Semisolids are stored in an incubator at 50ºC for 48 hours and then transferred to a
freezer at -5ºC for 48 hours.
Special evaluation tests

2- For creams: Determination of the emulsion type

FPQC Cream

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QC TESTS FOR CREAMS:

2- Particle size determination:

3- Weight Variation Test:

Special evaluation tests

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