دورية أكاديمية

DETERMINATION OF POLYSORBATES BY SPECTROPHOTOMETRY IN DRUGS BASED ON RECOMBINANT PROTEINS

التفاصيل البيبلوغرافية
العنوان: DETERMINATION OF POLYSORBATES BY SPECTROPHOTOMETRY IN DRUGS BASED ON RECOMBINANT PROTEINS
المؤلفون: A. D. Askretkov, P. M. Isaykina, S. A. Cherepushkin, N. V. Orlova
المصدر: Разработка и регистрация лекарственных средств, Vol 0, Iss 3, Pp 124-129 (2019)
بيانات النشر: LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2019.
سنة النشر: 2019
المجموعة: LCC:Pharmaceutical industry
مصطلحات موضوعية: валидация, рекомбинантные белки, полисорбат, твердофазная экстракция, твин, тиоцианат железа, Pharmaceutical industry, HD9665-9675
الوصف: Method of determination of polysorbate 20 and polysorbate 80 in recombinant protein drugs based on spectrophotometry has been designed. Isolation of polysorbate from solution is carried out by solid phase extraction followed by elution of polysorbate with acetonitrile. Acetonitrile solution is evaporated and then polysorbate is derivatized with ferrous-thiocyanate reagent. Obtained derivative is extracted into organic phase and optical density is measured. The most optimal conditions of derivatization, extraction into organic phase and measurment was chosen. The validation was performed: specificity, linearity, accuracy, precision, robustness, limit of quantification.
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: Russian
تدمد: 2305-2066
2658-5049
Relation: https://www.pharmjournal.ru/jour/article/view/469; https://doaj.org/toc/2305-2066; https://doaj.org/toc/2658-5049
URL الوصول: https://doaj.org/article/841b8c3eb6fc4e55bb23675a9958b18f
رقم الأكسشن: edsdoj.841b8c3eb6fc4e55bb23675a9958b18f
قاعدة البيانات: Directory of Open Access Journals