The test for uniformity of content of single-dose preparations is based on the assay of the individual contents of active substance(s) of a number of single-dose units to determine whether the individual contents are within limits set with reference to the average content of the sample.
The preparation complies with the test if each individual content is 85 to 115 percent of the average content. The preparation fails to comply with the test if more than one individual content is outside these limits or if one individual content is outside the limits of 75 to 125 percent of the average content.
If one individual content is outside the limits of 85 to 115 percent of the average content but within the limits of 75 to 125 percent, repeat the determination using another 20 dosage units. The preparation complies with the test if not more than one of the individual contents of the total sample of 30 dosage units is outside 85 to 115 percent of the average content and none is outside the limits of 75 to 125 percent of the average content.
Related: Contents Uniformity (Weight or Volume) of Packaged Dosage Forms
For capsules, powders other than for parenteral use, granules, pessaries and suppositories:
The preparation complies with the test if not more than one individual content is outside the limits of 85 to 115 percent of the average content and none is outside the limits of 75 to 125 percent of the average content. The preparation fails to comply with the test if more than three individual contents are outside the limits of 85 to 115 percent of the average content or if one or more individual contents are outside the limits of 75 to 125 percent of the average content.
Method
Determine the content of active ingredient(s) in each of 10 dosage units taken at random using the method given in the monograph or by any other suitable analytical method.Acceptance limits
For tablets, powders and suspensions for injection and ophthalmic inserts:The preparation complies with the test if each individual content is 85 to 115 percent of the average content. The preparation fails to comply with the test if more than one individual content is outside these limits or if one individual content is outside the limits of 75 to 125 percent of the average content.
If one individual content is outside the limits of 85 to 115 percent of the average content but within the limits of 75 to 125 percent, repeat the determination using another 20 dosage units. The preparation complies with the test if not more than one of the individual contents of the total sample of 30 dosage units is outside 85 to 115 percent of the average content and none is outside the limits of 75 to 125 percent of the average content.
Related: Contents Uniformity (Weight or Volume) of Packaged Dosage Forms
For capsules, powders other than for parenteral use, granules, pessaries and suppositories:
The preparation complies with the test if not more than one individual content is outside the limits of 85 to 115 percent of the average content and none is outside the limits of 75 to 125 percent of the average content. The preparation fails to comply with the test if more than three individual contents are outside the limits of 85 to 115 percent of the average content or if one or more individual contents are outside the limits of 75 to 125 percent of the average content.
If two or three individual contents are outside the limits of 85 to 115 percent of the average content but within the limits of 75 to 125 percent, repeat the determination using another 20 dosage units. The preparation complies with the test if not more than three individual contents of the total sample of 30 dosage units are outside the limits of 85 to 115 percent of the average content and none is outside the limits of 75 to 125 percent of the average content.
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