Pharmaceutical Substances. Requirements of the State Pharmacopoeia for Their Standardization

Abstract

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.

Keywords

• state pharmacopoeia of the russian federation
• pharmaceutical substances
• standardization