Standardisation of the method of residual organic solvent determination (review)

Standardisation of the method of residual organic solvent determination (review)

INTRODUCTION. An important quality attribute of medicines and excipients is the content of residual organic solvents (ROS). The general chapter on ROS (1.1.0008) of the State Pharmacopoeia of the Russian Federation (Ph. Rus.) does not provide analytical procedures for ROS identification, limit tests...

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Bibliographic Details
Main Authors: O. G. Kornilova, E. A. Smiryagin, V. L. Bagirova, M. A. Sumtsov
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’) 2024-12-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
residual organic solvents
ros
quality control
identification
limit tests
quantitative determination
gas chromatography
head-space injection systems
Online Access:https://www.vedomostincesmp.ru/jour/article/view/704
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