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Recently the USP has released a series of Notices of Intent to Revise for Chapter <711>Dissolution. The major change in this revision is the replacement of the current PVT Prednisone RS, used to perform the USP required dissolution equipment Performance Verification Test (PVT), with a brand-new standard called the Dissolution Performance Verification Standard – Prednisone. The current USP FAQ page for this Notice of Intent to Revise lists the expected date for the revision to take effect as 01-May-2023, at which point the old Prednisone Reference material stops being valid for performing PVT testing, and the use of the DPVS becomes mandatory.
In view of the short timeframe and absolute nature of the change, the dissolution community has had a series of pressing questions regarding the implementation of this new standard. To help provide answers to these, the In-Vitro Release and Dissolution Testing (IVRDT) Community would like to organize an interactive event with the USP where a technical representative from the USP will introduce the DPVS and offer the latest update on implementation, protocols, timelines, etc. This representative will then be available to answer questions in a structured way from a panel representing a cross-section of our community or moderated questions from event attendees.
- What is the new USP DPVS Calibrator
- How do I use it instead of the existing Prednisone
- When does this mandatory validation change come into effect