Type of Posting: Notice of Intent to Revise
Posting Date: 29–Oct–2021; updated 28–Jan–2022
Targeted Official Date: 01–Sep–2022, Interim Revision Announcement
Expert Committee: Dosage Forms Expert Committee
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Dosage Forms Expert Committee intends to revise General Chapter <711> Dissolution.
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.
The new Reference Standard is undergoing collaborative testing. It will be more sensitive to operational and mechanical variables of instrument setup, less sensitive to media degassing, and more reproducible. USP will conduct extensive outreach to stakeholders with additional information when the new Reference Standard is available.
It is anticipated that the proposed revision to General Chapter <711> will be published as an Interim Revision Announcement in Pharmacopeial Forum 48(2) [Mar. – Apr. 2022] pursuant to the Rules and Procedures. The comment period for this revision ends on May 31, 2022. In the absence of significant adverse comments, the proposed IRA may become official as early as on September 1, 2022, and will be coordinated with the date when this new USP Reference Standard is available.
An FAQ for this revision proposal is available here. Should you have any questions, please contact Margareth Marques, Senior Principal Scientist (mrm@usp.org).
CN-22-021-01
This Notice was updated on January 28, 2022 to add a link to the FAQ.