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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Veröffentlicht in:Pharmaceutical technology Europe 2012-04, Vol.24 (3), p.17
Hauptverfasser: Wadekar, Kashyap R, Ravi, Ponnaiah, Bhalme, Mitali, Rao, S Srinivasa, Reddy, K Vigneshwar, Kumar, L Sampath, Balasubrahmanyam, E
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Sprache:eng
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Zusammenfassung: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