This document outlines three tests - Test A, Test B, and Test C - for evaluating the uniformity of contents in pharmaceutical products. Test A is for tablets and powders for parenteral use, Test B is for capsules, powders, granules, and suppositories, and Test C is for transdermal patches. Each test specifies acceptable ranges for the average contents and individual unit contents compared to the labeled claim.

1. Chemical Tests

2. Assay of active ingredients
 Weigh 20 tablets, grind, take weight of
powder equal to one tablet.
 Analyze by the method prescribed in
monograph
 Results obtained are expressed as %age of
active ingredient as in single unit
 Compare with the standard
 Should be within specified limits usually
±10%

3. Contents of uniformity
 Based on assay of individual contents of
active ingredient
 Determine individual contents of active
ingredient of 10 units taken at random
 Test A
 (Tablets, Powder for parenteral use)
 Complies if contents lie between 85 -115% of
the average label claim

4.  Fails if more than one is out of this limit or
one is outside 75-125% limit
 If one is out of 85-115% but within
75-125% , repeat the procedure with 20
more samples
 Complies if not more than 1 is out of 15%
but all in 25%

5. Test B (capsules, powders, granules,
suppositories)
 Complies if not more than one is out of 85-115%
and all in 75-125%
 Fails if more than 3 individual contents are
outside the limit of 85-115%, or if one or more
contents are outside the limit of 75-125%
 If 2 or 3 are outside 85-115% but within
75-125% determine the contents of 20 more
samples
 Complies if not more than 3/30 are outside
85-115% but all lies in 75-125%.

6. Test C
 Transdermal patches
 Average contents of 10 units should be
between 90-110 % of the label claim and if
each unit is between 75-125%