Short-term Revision of USP Chapter on Dissolution Testing

Recommendation
10/11 September 2025
On 29 December 2011, the USP announced that the appropriate experts group of the USP had revised General Chapter <711> - Dissolution Testing. This revision will enter into force on 1st February 2012.
The background for the revision is the removal of Chlorpheniramine Maleate Extended-Release Tablets RS from the list of reference standards and from the Apparatus Suitability section.
The standard used until now had turned out and couldn't be replaced.
The USP is currently in the process of identifying replacement materials to be used in the Performance Verification Test for Apparatus 3.
The revised Chapter will be integrated in the second supplement of USP 35 - NF 30.
Further information is available in the Revision Bulletin - General Chapter <711> Dissolution as well as in the revised chapter.
Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Related GMP News
16.07.2025Inadequate Sampling and Component Testing Highlighted in FDA Warning Letter
16.07.2025EMA publishes new Product-Specific Bioequivalence Guidance
16.07.2025Revision of USP Chapter <1039> Chemometrics Published for Comments
16.07.2025Proposal for new USP Chapter <318> NMR Monomer Ratio Determination for Lactide-Glycolide Polymers
16.07.2025New USP Chapter <1221> on Ongoing Procedure Performance Verification (OPPV) Published for Comment
02.07.2025FDA Warning Letter: Missing Testing, No Stability Data, and Inadequate Raw Material Controls