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The USP has issued a Notice of Intent to Revise General Chapter <711> DISSOLUTION, which among other changes, introduces the use of new reference standard tablets called USP Dissolution Performance Verification Standard (DPVS).
What is the USP Dissolution Performance Verification Standard (DPVS)?
A new Prednisone reference standard that is more reproducible, more sensitive to operational and mechanical variables of instrument setup while less sensitive to media degassing. The packaging has also been changed to blister packs of 6 tablets packaged in an aluminum sachet to provide additional protection against moisture.
Click HERE to go to the USP DPVS FAQ page.
When does it come into effect?
The current schedule listed in the proposed revision has the DPVS becoming the only valid standard that may be used to perform Performance Verification Testing (PVT) starting 1-May-2023. Although already on sale, the DPVS may not be used to perform PVTs prior to this date.
What about PVTs performed before May using the current valid Prednisone lot (Lot #R154P0)?
Any PVT performed up to 28-APR-2023 will remain valid for the normal duration period each company uses. The USP will not require an additional PVT for these units using the new DPVS after 1-MAY-2023.
If the current schedule remains in effect, can Distek perform PVTS using the new DPVS starting on the 1st of May?
Yes. Distek has the new DPVS tablets in stock and a valid PVT protocol ready to be executed at your site as required.