Pharmaceutical Substances. Requirements of the State Pharmacopoeia for Their Standardization

The present article reviews the modern approaches for the standardization of synthetic pharmaceutical substances that are realized in the form of national pharmacopoeial standards - monographs published in State Pharmacopoeia of Russian Federation. The test parameters of pharmaceutical substances, t...

Full description

Saved in:
Bibliographic Details
Published inАнтибиотики и Химиотерапия Vol. 62; no. 5-6; pp. 63 - 67
Main Authors E. I. Sakanyan, T. B. Shemeryankina, A. V. Barmin, S. A. Zaitsev, T. A. Yarushok
Format Journal Article
LanguageRussian
Published LLC "Publishing House OKI" 01.05.2020
Subjects
pharmaceutical substances
standardization
state pharmacopoeia of the russian federation
Online AccessGet full text

Cover

More Information
Summary:The present article reviews the modern approaches for the standardization of synthetic pharmaceutical substances that are realized in the form of national pharmacopoeial standards - monographs published in State Pharmacopoeia of Russian Federation. The test parameters of pharmaceutical substances, the methods for their determination, and the applicable regulatory requirements involved in the pharmacopoeial monographs should be reproducible for every substance declared under the appropriate name.
ISSN:0235-2990