Determination of Organic Impurities in Combination Drugs

Methodological approaches to the control of organic impurities in drugs containing two and more active pharmaceutical ingredients are reviewed. Approaches of leading foreign pharmacopoeias (British, USA, Japanese) to assessing impurity profiles in combination drugs are analyzed. The methods for asse...

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Bibliographic Details
Published in:Pharmaceutical chemistry journal 2017-05, Vol.51 (2), p.126-129
Main Authors: Matveeva, O. A., Kovaleva, E. L.
Format: Article
Language:English
Subjects:
Drugs
Medicine
Methods of Analysis and Process Control
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
Structure of Chemical Compounds
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Summary:Methodological approaches to the control of organic impurities in drugs containing two and more active pharmaceutical ingredients are reviewed. Approaches of leading foreign pharmacopoeias (British, USA, Japanese) to assessing impurity profiles in combination drugs are analyzed. The methods for assessing impurities that carry the largest safety risks for combination drugs are determined. It is demonstrated that a unified approach to the control of organic impurities in combination drugs is needed.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-017-1570-y