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%
