Friday, 18 November 2016

Weight variation test (uniformity of weight)
   Weigh 20 tablet selected at random, each one individually . X1, X2, X3… Xz
Determine the average weight. X= (X1+X2 +X3+…+ Xz)/20
Limit:
Upper limit = average weight + (average weight  % error)
Lower limit = average weight - (average weight  % error)
The individual weights are compared with the upper and lower limits.
Not more than two of the tablets differ from the average weight by more than the % error listed, and no tablet differs by more than double that percentage.
Weight variation tolerances for uncoated tablets
USP -NF standards
SN
Average wt. of tablet(mg)
Max. % difference allowed
1
130 or Less
10%
2
130-324
7.5%
3
More than 324
5%





Indian Pharmacoepia Standards
SN
Average wt. of tablet(mg)
Max. % difference allowed
1
84  or Less
10%
2
84-  250
7.5%
3
More than 250
5%


Content Uniformity Test:

It is an official test. Randomly select 30 tablets. 10 of these assayed individually. The Tablet pass the test if 9 of the 10 tablets must contain not less than 85% and not more than 115% of the labeled drug content and the 10th tablet may not contain less than 75% and more than125 % of the labeled content. If these conditions are not met, remaining 20 tablets assayed individually and none may fall outside of the 85 to 115 % range.

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