Proposal for Slightly Revised USP Chapter <711> Dissolution Published
Recommendation
6/7 May 2025
Challenges and Solutions for Packaging / Devices & Single Use Systems
Register now for ECA's GMP Newsletter
In November 2021, we reported that the Dosage Forms Expert Committee intends to revise General Chapter <711> Dissolution. Please read the related news article for more information.
The new version of the chapter was now published for comments in the current Pharmacopeial Forum, PF 48(2). The briefing note states that the "proposal is based on the version of the chapter to be official on May 1, 2022. The purpose of this revision is to include an option of using a new USP Reference Standard, USP Dissolution Performance Verification Standard-Prednisone RS, to qualify the Dissolution Apparatus 1 (basket) and Dissolution Apparatus 2 (paddle), in addition to USP Prednisone Tablets RS, which is already included in the official version of this chapter."
The proposal can be consulted after registration on the Pharmacopeial Forum website. Comments can be submitted until May 31, 2022. In the absence of significant adverse comments, it is proposed to implement the new revision via an Interim Revision Announcement with an official date of September 1, 2022.
Related GMP News
12.03.2025EMA publishes Considerations regarding the Implementation of ICH M13A on Bioequivalence
12.03.2025Proposed Update to USP <1058> on Analytical Instrument and System Qualification
06.03.2025Eurachem publishes Leaflet on Analytical Equipment and Systems
06.03.2025Further Modifications to USP Chapter <621> Chromatography Published for Comment
26.02.2025FDA Warning Letter Highlights Responsibilities of Contract Testing Laboratories
26.02.2025New ISO/TR 33402:2025 on Reference Material Preparation