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Analytical Method Selection for drug Product dissolution Testing Qingxi Wang1, 2, Decheng Ma1, and John P. Higgins1. e-mail: Abstract This article provides an overview of Analytical methods applied to the dissolution testing of various pharma- ceutical products. The benefits and limitations of each Method are discussed with respect to dynamic range, selectivity,extent of automation,efficiency,and robustness. This article presents useful guidance on Analytical Method Selection for pharmaceutical development scientists and quality control personnel who are faced with the challenges of dissolution testing during the drug Product life cycle. Introduction Selection at different stages of drug Product life D. issolution is a characterization test commonly cycle is presented. used by the pharmaceutical industry to guide formulation design and control Product Direct Spectroscopic and quality.
6 Dissolution Technologies | AUGUST 2006 Analytical Method Selection for Drug Product Dissolution Testing Qingxi Wang 1,2, Decheng Ma1, and John P. Higgins1 e-mail: Qingxi_Wang@Merck.com IntroductionD issolution is …
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