27 European Pharmacopoeia (EP) Certificate of Suitability The API manufacturer initiates it by sending the synthesis route and basic data together with normal impurity (intermediers + decomposition products) samples to the European Department of Quality of Medicines (EDQM) EDQM checks whether the EP monograph methods are suitable to detect/quantify impurities If yes, the Certificate (referred to as Certificat of European Pharmacopoeia, CEP) issued, specific to the given API (manufacturer, synthesis)
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