N-Nitroso Nilotinib (CAS 2925306-68-7), auch als N-Nitroso Nilotinib Impurity 1 bezeichnet, ist eine nitrosaminbezogene Prozessverunreinigung des Tyrosinkinasehemmers Nilotinib. Mit der Summenformel C28H21F3N8O2 und einer Molmasse von 558.53 g/mol trägt die Verbindung eine N-Nitroso-Funktion an einem stark substituierten heteroaromatischen Gerüst, was mit einer Nitrosierung während der Synthese oder durch Kontakt von Aminvorstufen mit nitrosierenden Reagenzien vereinbar ist. Aufgrund des potenziellen genotoxischen Risikos ist sie im Rahmen von ICH M7 zu bewerten. Die sichere Bestimmung erfordert typischerweise LC-MS/MS für Spurenmengen, ergänzt durch hochauflösende MS und, falls möglich, orthogonale LC-UV- oder GC-MS-Bestätigung.
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