Discriminatory Dissolution Method Development and ...
the development of an appropriate in vitro dissolution method is essential in the prediction of in vivo ... proper formulation selection (selection of excipients) and optimizing the manufacturing process (e.g., compression ... The availability of a discriminatory dissolution method for use in either quality control testing or product evaluation
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www.uspnf.comThe dissolution characteristics of an oral formulation should be evaluated in the physiologic pH range of 1.2 to 6.8 (1.2 to 7.5 for modified-release formulations). During method development, it may be useful to measure the pH before and after a run to discover whether the pH changes during the test. Selection of the most appropriate