End-to-end Standardization of Original Medicines when Determining Related Impurities

Introduction. For tablets “Malоben, 60 mg” and “Etmaben, 300 mg”, permission was received to conduct phase I clinical trials, so they required a full cycle of research and standardization.Aim. Development of a unified analytical procedure for the determination of related impurities in samples (RS, A...

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Bibliographic Details
Main Authors: Yu. E. Generalova, I. I. Terninko, A. B. Zelentsova
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2023-12-01
Series:Разработка и регистрация лекарственных средств
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Online Access:https://www.pharmjournal.ru/jour/article/view/1647
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