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Research Article

Problems with a Pharmacopoeial Dissolution Test Using a Binary Medium

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Pages 443-452 | Published online: 20 Oct 2008
 

Abstract

Tablets of a low dose chlorthalidone formulation failed to meet the USP specification for dissolution in aqueous methanol though the rate of dissolution in water or dilute acid indicated that their dissolution characteristics were satisfactory. It has been shown that this is due to methanol retarding disintegration, and that this can occur with a wide range of different placebo formulations. Predisintegration of the tablet in the aqueous portion of the mixture is recommended.

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