USP-NF Publishes Notice of Intent to Revise General Chapter <711> Dissolution

Recommendation

24/25 April 2024

QC Compliance Manager - Live Online Training

In a USP–NF Compendial Notice published 29 October 2021, it was announced that the Dosage Forms Expert Committee intends to revise General Chapter <711> Dissolution. It is anticipated that the proposed revision will be published as an Interim Revision Announcement (IRA) in Pharmacopeial Forum 48(2) in March 2022, with the comment period ending on 31 May 2022. Thus, the revision may become official as early as on 01 September 2022.

"The purpose of this revision is to include an option for using a new USP Reference Standard, Dissolution Performance Verification Standard – Prednisone, to qualify the Dissolution Apparatus 1 (basket) and Dissolution Apparatus 2 (paddle), in addition to the existing USP Reference Standard Prednisone Tablets which is included in the current Chapter."

According to the Notice, the new reference standard will be more sensitive to operational and mechanical variables of instrument setup, less sensitive to media degassing, and more reproducible.

For further information, please see the Notice of Intent to Revise published on the USP-NF website.