USP <1092> - The Dissolution Procedure - Development and Validation

What it says

General Chapter <1092> provides guidance on developing and validating dissolution test methods, addressing selection of appropriate testing conditions, discriminating power, and the validation characteristics needed to demonstrate a dissolution method reliably reflects genuine product quality differences.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• While Chapter <711> describes dissolution testing apparatus and general methodology, this chapter addresses the upstream question of how to actually develop and validate a dissolution method specific to a given product, ensuring the method is scientifically appropriate before it becomes the routine release test.
• Discriminating power, the method's ability to actually detect meaningful differences in product performance, is emphasised as a central development goal, since a non-discriminating method that passes virtually any batch provides little genuine quality assurance value.
• Method development under this chapter should be informed by an understanding of the drug substance's solubility characteristics and the dosage form's release mechanism, connecting dissolution method design back to fundamental product understanding developed during pharmaceutical development.

What inspectors look for

• Whether dissolution method development documentation demonstrates the method was actually evaluated for discriminating power, not simply adopted because it produced consistently passing results.
• Whether dissolution method validation followed a structured approach addressing the specific validation characteristics this chapter describes.
• Whether a dissolution method continues to be periodically reassessed for continued appropriateness as manufacturing experience with the product accumulates.

Related regulations