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What is Hydrolytic Degradation Profiling of Ezetimibe by HPLC Method about?

ABSTRACT Background Forced degradation profiling is used to facilitate the development of analytical methodology, to gain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability and it also part of new drug application (NDA) registration. Objectives To develop and validate a novel RP-HPLC method for determination of ezetimibe and forced degradation products and establish its intrinsic stability by forced degradation study. Methods Ezetimibe and its forced de

Author

TJPRC Publications

Language

EN