PharmPK Discussion - Impurity as metabolite

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On 7 May 2011 at 17:14:12, jigneshkotecha.aaa.torrentpharma.com sent the message


Dear all,
Referring the ICH guidance document on impurity testing, following  statement is mentioned;
"Impurities which are metabolites present in animal or human studies are  qualified. "
The queries are,  1) what percentage of metabolite (AUC  or ______) is  considered for qualification? 2) what percentage of impurity is allowed  in API once the metabolite AUC (___%) is established?
Thanks
regards,
Jignesh Kotecha Torrent Research Centre, Gandhinagar, Gujarat, India

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