Varenicline Diamine Impurity, CAS 230615-69-7, bezeichnet die aminhaltige prozessbedingte Verunreinigung 2,3,4,5-Tetrahydro-3-(trifluoracetyl)-1,5-methano-1H-3-benzazepin-7,8-diamin. Mit der Summenformel C13H14F3N3O und einem Molekulargewicht von 285,26 g/mol weist sie auf unvollständige Umsetzung oder Nebenreaktionen in der Vareniclin-Synthese hin, insbesondere im Bereich der Aminierung und der Einführung der Trifluoracetylgruppe. Die starre benzazepinische Azabicyclus-Struktur mit vicinalen aromatischen Aminen beeinflusst Retention und Ionisierung. Für die Spurenbestimmung werden üblicherweise LC-MS/MS, LC-UV mit orthogonaler Bestätigung sowie gegebenenfalls hochauflösende Massenspektrometrie im Rahmen einer ICH-M7-orientierten Bewertung eingesetzt.
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