Developing validating dissolution procedures

The amount of discard is determined from the results.

mentions the use of solutions made with not more than 5% organic solvent when evaluating Accuracy/Recovery and Linearity and Range.

A dissolution test is really a simple concept; a tablet or capsule is placed into a known volume of media, and as it dissolves the resulting solution is sampled over time, and assayed (often by high performance liquid chromatography [HPLC], but also by spectrophotometry) for the level of active pharmaceutical ingredient (API) present.

However, the design, development, and validation of the procedure can be quite involved, especially when one considers that not only must the dissolution procedure be developed and validated, but also any analytical technique used for the assay.

The adsorption of the analyte to the filter may be saturable, meaning that it can only adsorb a certain amount of the analyte.

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 dissolution procedure has several distinct components.

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Agent: Stephanie Sinclair Silmy Abdullah was born in Bangladesh.When she was a toddler, she moved with her family to the Middle East.She immigrated to Canada in 1998 and since then, has considered Toronto her home.Type of Posting: General Announcement Posting Date: 22–Nov–2013 Expert Committee: General Chapters—Dosage Forms The General Chapters—Dosage Forms Expert Committee is proposing to revise General Chapter and the associated Stimuli article have been approved for publication in Pharmacopeial Forum 40(1) [Jan.–Feb. Both are being presented in advance of publication of PF 40(1) to allow additional time for public review and comment.Comments will be accepted until March 31, 2014, the end of the comment period for Pharmacopeial Forum 40(1).

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