Proposed Change to Acceptance Criteria for Dissolution Performance Verification Testing

Abstract

USP Dissolution <711> specifies performance verification testing (PVT) of dissolution Apparatus 1 and 2. Acceptance criteria are determined from a collaborative study and apply per tablet; i.e., each of the six tablets tested must fall within the specified acceptance criteria in order to pass. In this Stimuli article, USP proposes changing the form of the acceptance criteria to one that is consistent with the International Organization for Standardization's (ISO's) recommendations for proficiency testing. The new criteria would apply to the laboratory's average and standard deviation of the tablets tested. The article explains the rationale and shows the criteria that would be applied to USP Lot P Prednisone Reference Standard (RS) Tablets and USP Lot Q Salicylic Acid RS Tablets.