Weight Variation Calculation in Pharmaceutical Industry

The weight variation calculation is a in-process quality control technique is used to determine the uniformity of dosage unit in pharmaceutical dosage forms.

Test Procedure

Weigh 20 units individually, and determine the average weight. The requirements are met if the weights of Not more than 2 of the tablets differ from the average weight by more than the percentage listed in pharmacopoeia and no tablet differs in weight by more than double that percentage.

Acceptance Criteria

Weight Variation Tolerances for Uncoated Tablets, Film-Coated Tablets, and Coated Tablets as  per BP and USP are given below -

Weight Variation Limit as per BP/EP

*When the average mass is equal to or below 40 mg, the preparation is not submitted to the test for uniformity of mass but to the test for uniformity of content of single-dose preparations.

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