Fenofibrate EP Impurity B, auch als Fenofibrate Related Compound B und Fenofibrinsäure bezeichnet, trägt die CAS-Nummer 42017-89-0 und besitzt die Summenformel C17H15ClO4 bei einer Molmasse von 318,75 g/mol. Strukturell handelt es sich um den hydrolysierten Carbonsäuremetaboliten von Fenofibrat, der durch Esterhydrolyse während Synthese, Lagerung oder oxidativer Zersetzung entsteht und kein eigenständiges neues Gerüst darstellt. Als verfahrens- und abbaubedingte Verunreinigung erfordert die Identitätszuordnung typischerweise LC-MS/MS, während die Gehaltsbestimmung meist mittels LC-UV oder HPLC im Vergleich mit Referenzmaterial erfolgt; nach Derivatisierung kann auch GC-MS eingesetzt werden. Es handelt sich nicht um ein Nitrosamin und üblicherweise nicht um eine ICH-M7-genotoxische Verunreinigung.
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