Uniformity of Weight

This test is only applicable to those capsules that need to comply with the test for uniformity of content of the main active ingredient. Weigh the capsule and open the capsule carefully without any spillage to remove the encapsulated contents completely. For soft gelatin capsules, the shell has to be washed with ether or any other suitable solvent and allowing the shell to stand until the odor of the solvent gets completely removed. Weigh the empty shell again and the difference between the weights is the actual weight of contents. Repeat the procedure for another 19 capsules. Record the average weight. Not more than two of the individual weights (capsules) should deviate from the average weight by more than the specified percentage deviation shown in Table 5.5 and none of the capsules to deviate by more than twice that percentage.

 

Table 5.5 Official Limits for Uniformity of Weight

Average Weight of Capsule ContentsPercentage Deviation (%)
Less than 300 mg10
300 mg or more7.5

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