Atorvastatin EP Impurity C, auch Atorvastatin Related Compound C, Fluoroatorvastatin oder Atorvastatin Difluoro Analog genannt, ist eine halogenierte, prozessbezogene Verunreinigung des HMG-CoA-Reduktasehemmers Atorvastatin. Die Struktur mit CAS 693794-20-6, der Summenformel C33H34F2N2O5 und dem Molekulargewicht 576,64 g/mol weist auf ein difluoriertes lipophiles Analogon und nicht auf ein einfaches Abbauprodukt hin. Die Entstehung wird typischerweise mit fluorierungsbedingten Nebenreaktionen oder unvollständiger Entschützung während der Wirkstoffsynthese verknüpft. Für Identifizierung und Gehaltsbestimmung werden üblicherweise LC-MS/MS, hochauflösende LC-MS und orthogonale HPLC-UV-Verfahren eingesetzt, im Rahmen der ICH-Q3A- und Q3B-Bewertung.
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