Modern Approaches to the Development of Reference Standards for Quality Assessment of Drug Substances

Reference standards, including pharmacopoeial reference standards, are widely used for quality assessment of drug substances. Leading global pharmacopoeias contain monographs regulating the requirements for the classification, attestation, and use of reference standards. The drug standardization sys...

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Bibliographic Details
Published inPharmaceutical chemistry journal Vol. 49; no. 11; pp. 776 - 778
Main Authors Merkulov, V. A., Sakanyan, E. I., Klimov, V. I., Shemeryankina, T. B., Yashkir, V. A., Barmin, A. V.
Format Journal Article
LanguageEnglish
Published New York Springer US 01.02.2016
Springer
Subjects
Drugs
Medicine
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
pharmacopoeial reference standards
pharmacopoeial monograph
regulation
reference standards
drug substances
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Summary:Reference standards, including pharmacopoeial reference standards, are widely used for quality assessment of drug substances. Leading global pharmacopoeias contain monographs regulating the requirements for the classification, attestation, and use of reference standards. The drug standardization system in the Russian Federation, which includes drug substances, requires revision for the creation and attestation of national reference standards, including pharmacopoeial ones.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-016-1369-2