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...

وصف كامل

التفاصيل البيبلوغرافية
المؤلفون الرئيسيون: N. A. Epshtein, V. L. Sevastianova, A. I. Koroleva
التنسيق: مقال
اللغة:Russian
منشور في: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2019-01-01
سلاسل:Разработка и регистрация лекарственных средств
الموضوعات:
الوصول للمادة أونلاين:https://www.pharmjournal.ru/jour/article/view/624