Methodological aspects of determining molecular mass distribution of dextrans by size-exclusion chromatography for various groups of medicines

Methodological aspects of determining molecular mass distribution of dextrans by size-exclusion chromatography for various groups of medicines

The article analyses the results of quality evaluation of dextran substances and medicines produced thereof which was carried out by the Institution as part of pre-authorisation testing and involved the analysis of the «molecular mass distribution» parameter. The article gives recommendations on how...

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Bibliographic Details
Main Authors: R. S. Smirnov, E. V. Ivanainen, A. I. Lutseva, O. A. Vaganova, D. A. Orlov
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:
декстраны
молекулярная масса
молекулярно-массовое распределение
эксклюзионная хроматография
экспертиза качества
регистрация лекарственных средств
нормативная документация
dextrans
molecular mass
molecular-mass distribution
size-exclusion chromatography
quality evaluation
marketing authorization
Online Access:https://www.vedomostincesmp.ru/jour/article/view/110
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