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Determination and Acceptance limits of Uniformity of Content of Single-Dose Preparations


Learn how to determine the Uniformity of Content in all pharmaceutical doses forms.
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.

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 per cent 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 per cent of the average content.
If one individual content is outside the limits of 85 to 115 per cent of the average content but within the limits of 75 to 125 per cent, 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 per cent of the average content and none is outside the limits of 75 to 125 per cent 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 per cent of the average content and none is outside the limits of 75 to 125 per cent 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 per cent of the average content or if one or more individual contents are outside the limits of 75 to 125 per cent of the average content. If two or three individual contents are outside the limits of 85 to 115 per cent of the average content but within the limits of 75 to 125 per cent, 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 per cent of the average content and none is outside the limits of 75 to 125 per cent of the average content.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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