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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?
Jignesh Kotecha Torrent Research Centre, Gandhinagar, Gujarat, India
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