USP Standard for Dissolution Testing withdrawn

Recommendation

19 September 2019
Copenhagen, Denmark

Stability Testing for Biological/Biotechnological Drug Substances and Drug Products

In a notice from 20 December 2011 the United States Pharmacopeia (USP) has notified that Chlorpheniramine Maleate Extended-Release Tablets RS will be withdrawn as of 1 February 2012.

These tablets had been used for testing the Performance Verification Suitability according to the General Chapter <711> for Apparatus 3.

This withdrawal is due to the fact that no suitable replacement candidate has been found to date.

USP remains convinced that a Performance Verification Test is a critical element in the qualification of dissolution apparatuses.

During the ECA Conference "Dissolution Testing - Development - Quality Control - and in vivo Relevance" taking place from 17-19 October 2012 in Berlin, the newest USP requirements concerning the qualification of apparatuses will be presented and compared to the FDA requirements on mechanical qualification.

Please also read USP's complete notice.

Author:
Dr. Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)