Control of Organic Impurities in Semisynthetic Antibiotics

In 2012, the European Medicines Agency (EMA) adopted a guideline, which divided all antibiotics into groups according to the manufacturing process and established acceptance criteria for organic impurities for each of the groups.The aim of the study was to justify the requirements and methodological...

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Bibliographic Details
Main Authors: E. L. Kovaleva, K. S. Arhipova, E. A. Bulova, A. A. Stralkovskaya, O. O. Terentieva
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2022-10-01
Series:Регуляторные исследования и экспертиза лекарственных средств
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Online Access:https://www.vedomostincesmp.ru/jour/article/view/479
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