Recent Changes Concerning the USP Dissolution Performance Verification Test

On 20 November 2009, the American Pharmacopoeia (USP) published an article on the changes regarding the Dissolution Performance Verification Test that came into force on 1 December 2009.

Starting from 1 December 2009, the use of Salicylic Acid Tablets RS is no longer mandatory for USP Dissolution Apparatus 1 and 2 during the Performance Verification Test (PVT). However, Prednisone Tablets RS still have to be used for Apparatus 1 and 2, and Chlorpheniramine Maleate Extended-Release Tablets RS, for the USP Dissolution Apparatus 3.

The details of the test methods and of the acceptance criteria can be found in the corresponding Technical Data Sheets, which can also be viewed on the Internet.

On 1 December, a change to General Chapter <711> also came into operation, consisting in the removal of the requirement to individually test certain tablets. This change enables the USP to move from the former acceptance criterion for the individual tablet to a new approach to the acceptance criteria later on. These new criteria are meant to be passed on in the Technical Data Sheet.

At the moment, the USP is working on new batches of Prednisone Tablets RS and Chlorpheniramine Maleate Extended-Release Tablets RS. For these new batches of reference materials, the USP will lay down new acceptance criteria taking into account the mean and the rel. standard deviation for a previously defined number of tablets.

The USP will announce further details on the website as soon as the competent USP Expert Committee has given its consent.

The complete document can be found here.

And the data on the individual USP RS tablets for the Performance Verification Test can be found here.

PS: The new USP Performance Verification Test is among the topics of ECA's education course "Dissolution Testing" to be held in Berlin, Germany, from 13 to 15 October 2010. A guided tour of the Dissolution Laboratories at Bayer Schering Pharma AG is part of the programme. Further information on the seminar can be found here.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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