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USP Dissolution Performance Verification Standard

As of May 1, 2023, the USP Prednisone tablets with the article number USP-1559505, batch R154P0, will no longer be distributed. They will be replaced by the USP Dissolution Performance Verification Standard with the article number USP-1222818 Prednisone (30 tablets). These can be ordered from Eurofins PHAST GmbH: either by e-mail to reference-stan- dards@phast.com or in the webshop at www.reference-standards.com.

The Dissolution Performance Verification Standard is considered by the USP to be more sensitive to operational and mechanical variables of the device setting, less sensitive to media degassing and more reproducible. In addition, the new Prednisone formulation has a different dissolution profile than its predecessor.

Did you know that... after the revised USP National Formulary (NF) General Chapter <71>; Dissolution comes into force on May 1, 2023, the USP Dissolution Performance Verification Standard USP-1222818 Prednisone is the only officially valid replacement to meet the corresponding NF requirements?

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