Uniformity of Content

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Uniformity of Content is a pharmaceutical analysis technique for the quality control of hard shell gelatin capsules. It is carried out as follows:

Select 10 capsules at random, and empty contents of each capsule carefully in a suitable container. Using a suitable analytical method, assay the individual content of active in each capsule.

The preparation complies if not more than one (all within limits) individual content is outside the limits of 85 to 115 % of the average content and none is outside the limits of 75 to 125 % of the average content. The preparation fails to comply with the test if more than 3 individual contents are outside the limits of 85 to 115 % of the average content or if one or more individual contents are outside the limits of 75 % to 125 % of the average content.