Comparative analysis of the requirements for the quality of excipients in Russia and abroad. Problems of biological, medical and pharmaceutical chemistry

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The article presents the main classification of auxiliary substances used in the composition of medicines according to their functional purpose, a comparative analysis of regulatory documents regulating the quality of auxiliary substances included in the composition of medicines, starting from the stage of pharmaceutical development. Special attention is paid to the list of quality indicators, the inclusion of which in pharmacopoeia articles or specifications is mandatory.

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作者简介

K. Sakanyan

Federal State Budgetary Educational Institution of Higher Education "MIREA – Russian Technological University"

编辑信件的主要联系方式.
Email: sakanyan@karen.ru
ORCID iD: 0000-0002-2028-2776

Ph.D. (Pharm.), Leading Research Scientist, Department of Biotechnology and Industrial Pharmacy

俄罗斯联邦, 78 Vernadsky Avenue, Moscow, 119454

S. Kedik

Federal State Budgetary Educational Institution of Higher Education "MIREA – Russian Technological University"

Email: kedik@mirea.ru
ORCID iD: 0000-0003-2610-8493

Dr.Sc. (Tech.), Professor, Head of Department of Biotechnology and Industrial Pharmacy

俄罗斯联邦, 78 Vernadsky Avenue, Moscow, 119454

A. Panov

Federal State Budgetary Educational Institution of Higher Education "MIREA – Russian Technological University"

Email: alpa602@mail.ru
ORCID iD: 0000-0002-1603-143X

Ph.D. (Chem.), Associate Professor of the Department of Biotechnology and Industrial Pharmacy

韩国, 78 Vernadsky Avenue, Moscow, 119454

参考

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