5-((4-(3-Carbamoyl-1-(4-methoxyphenyl)-7-oxo-1,4,5,7-tetrahydro-6H-pyrazolo[3,4-c]pyridin-6-yl)phenyl)(nitroso)amino)pentansäure, CAS 3094994-84-7, ist eine nitrosaminbezogene Apixaban-Verunreinigung mit der Summenformel C25H26N6O6 und einer Molmasse von 506,51 g/mol. Die Verbindung trägt eine N-Nitroso-Aminosäure-Seitenkette am Apixaban-Gerüst, was auf Entstehung unter nitrosierenden Bedingungen, durch Nitritspuren oder als prozessbedingtes Nitrosierungsprodukt eines Amins hinweist. Als potenzielle genotoxische Verunreinigung unterliegt sie dem risikobasierten Kontrollansatz nach ICH M7 sowie einschlägigen Nitrosamin-Leitlinien. Für die Spurenanalytik werden üblicherweise LC-MS/MS, hochauflösende LC-MS und orthogonale Bestätigungsverfahren mit detaillierter Fragmentationsauswertung eingesetzt.
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