Developing validating dissolution procedures

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It also is used commonly as a predictor of a drug product's in-vivo performance.

To help satisfy dissolution requirements, the USP provides information in the way of a general chapter on dissolution, as well as related chapters on disintegration and drug release (1–3).

If that is the case, a specific discard volume of sample solution filtrate can be found that allows subsequent filtrate concentration to be representative of the concentration of analyte dissolved in the sample.

The General Chapters—Dosage Forms Expert Committee 2010–2015 placed the review and possible revision of The Dissolution Procedure: Development and Validation 1092 on its work plan for the 2010–2015 revision cycle (2011) .

Drug Regulations has prepared this presentation based on the proposed chapter.

Validation of the analysis should be done to assure the results over the range expected for the analysis when it is applied to the product.

The dissolution performance test is a required test for all solid oral dosage forms for product release testing.

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