Proposed Change for Dissolution Performance Verification Testing

GMP News
6 June 2007

Proposed Change for Dissolution Performance Verification Testing

USP has published a proposal in Pharm. Forum Vol. 33 (3) from May – June 2007 to change the Acceptance Criteria for the Dissolution Performance Verification Testing. USP General Chapter <711> specifies performance verification testing for dissolution Apparatus Type 1 and 2. Each of the six tablets tested must fall within the specified acceptance criteria in order to pass. The USP proposes changing the form of the acceptance criteria to one that is consistent with the ISO recommendation for proficiency testing. The new criteria would apply to the laboratory's average and standard deviation of the tablets tested. This article published in Pharmacopeial Forum explains the rationale and shows the criteria that would be applied to Prednisone Reference Standard (RS) Tablets and USP Lot Q Salicylic Acid RS Tablets.

Learn everything about this topic in ECA's Education Course "Dissolution Testing" on 27-29 June 2007 in Berlin. The current regulatory requirements will be presented and key issues of dissolution testing (equipment qualification including USP calibrator tablets, specifications for dissolution tests, validation of dissolution methods and transfer of dissolution test methods) will be discussed in interactive workshops.

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

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