RECOMMENDATIONS OF THE EUROPEAN PHARMACOPOEIA «ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS» AND THEIR RESTRICTIONS FOR THE METHODS OF IMPURITIES DETERMINATION

The recommendations of admissible corrections of the chromatographic conditions provided in chapter 2.2.46 of the European Pharmacopeia in the section "Adjustment of chromatographic conditions" are examined. Based on experience of the investigation of robustness of HPLC and UPLC methods an...

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Bibliographic Details
Main Authors: N. A. Epshtein, V. L. Sevastianova, A. I. Koroleva
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2019-01-01
Series:Разработка и регистрация лекарственных средств
Subjects:
Online Access:https://www.pharmjournal.ru/jour/article/view/624