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Dissolution testing: methodology development

Published on December 31, 2025   38 min

A selection of talks on Metabolism & Nutrition

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0:00
Dear colleagues, let me introduce my presentation, Dissolution Testing: Methodology Development. My name is Igor Shohin. I'm a Doctor of Pharmaceutical Sciences, CEO of LLC Center of Pharmaceutical Analytics.
0:20
So let's start our talk with regulatory documents, which regulate all issues about dissolution testing methods development. The main document is USP Monograph 1092 the dissolution procedure: development and validation. It should be noted that this monograph was completely rewritten several years ago, so this monograph is really actual and important. That second USP monograph, which is required for this topic is assessment of solid oral drug products performance and interchangeability, bioavailability, bioequivalence, and dissolution. And also, I would like to mention two FDA guidances. The first one is dissolution testing of immediate-release solid oral dosage forms, and the second is dissolution testing and acceptance criteria for immediate-release solid oral dosage forms from drug products containing high solubility drug substances. I would like to mention that the first FDA guidance seems to be old, 1997. But it is still actual and very important.

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