Evaluating impurities in drugs - Part III

Metabolite impurities are byproducts formed in the body after a drug substance is ingested. During metabolism, the API and drug product in the body are exposed to various enzymes, from which metabolite impurities can be formed. Drug metabolism is traditionally divided into two phases: metabolic (i.e...

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Bibliographic Details
Published in:Pharmaceutical technology Europe 2012-04, Vol.24 (3), p.17
Main Authors: Wadekar, Kashyap R, Ravi, Ponnaiah, Bhalme, Mitali, Rao, S Srinivasa, Reddy, K Vigneshwar, Kumar, L Sampath, Balasubrahmanyam, E
Format: Article
Language:English
Subjects:
Chemicals
Chromatography
Clinical trials
Drugs
Metabolism
Metabolites
Phenols
Toxicity
Online Access:Get full text
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Summary:Metabolite impurities are byproducts formed in the body after a drug substance is ingested. During metabolism, the API and drug product in the body are exposed to various enzymes, from which metabolite impurities can be formed. Drug metabolism is traditionally divided into two phases: metabolic (i.e., hepatic) clearance, and the Phase I and Phase II process.
ISSN:1753-7967