Substantiation of conditions for determination of related substances in bisoprolol fumarate by HPLC

Substantiation of conditions for determination of related substances in bisoprolol fumarate by HPLC

The article summarizes the results of information analysis of bisoprolol fumarate synthesis methods which differ in the number of stages and in raw materials used, and are associated with the major identified impurities A, E and G, according to the European Pharmacopoeia (Ph. Eur.). The authors perf...

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Bibliographic Details
Main Authors: O. A. Baturina, E. V. Chaykovskaya, E. P. Gernikova, T. N. Bokovikova, L. A. Stronova, Yu. R. Biglova, S. A. Manaeva, E. S. Tolmacheva
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’) 2018-02-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
бисопролола фумарат
схема синтеза
родственные примеси
высокоэффективная жидкостная хроматография
оптимальные условия определения
критерии пригодности системы
bisoprolol fumarate
synthesis method
related substances
high-performance liquid chromatography
ideal conditions for determination
system suitability criteria
Online Access:https://www.vedomostincesmp.ru/jour/article/view/136

Internet

https://www.vedomostincesmp.ru/jour/article/view/136

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