N-Nitroso-Upadacitinib (Möglichkeit 1) ist eine nitrosaminbezogene Prozessverunreinigung von Upadacitinib, die plausibel durch Nitrosierung des Piperidin- oder amidassoziierten Stickstoffs unter Bedingungen entstehen kann, in denen nitrosierende Spezies während Synthese, Lagerung oder durch Reagenzienrückstände gebildet werden. Mit der Summenformel C17H18F3N7O2 und einer Molmasse von 409,4 g/mol gehört die Verbindung zur Klasse potenziell mutagener Verunreinigungen im Sinne der ICH-M7-Bewertung, da N-Nitroso-Funktionen typischerweise mit genotoxischer Relevanz assoziiert sind. Für Strukturbeweis und Spurenquantifizierung werden üblicherweise LC-MS/MS, hochauflösende MS und, sofern die Flüchtigkeit dies erlaubt, GC-MS mit selektiver Reaktionsüberwachung eingesetzt.
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