Tofacitinib Amine Impurity\Tofacitinib Inhouse Impurity A
Beschreibung
Tofacitinib N-Descyanoacetyl-Impurity, auch als Tofacitinib-Amin-Impurity bezeichnet, ist ein prozessbezogenes synthetisches Zwischenprodukt-Restniveau, das mit dem Aufbau der Tofacitinib-Seitenkette verbunden ist. CAS 477600-74-1, Summenformel C13H19N5 und Molekulargewicht 245,32 g/mol, kennzeichnen eine basische heteroaromatische Aminverbindung ohne die Cyanacetyl-Funktionalität des Ausgangsintermediats. Sie wird typischerweise als Routen-Impurität aus unvollständiger Acylierung, Deprotektivierung oder hydrolytischer Umwandlung während der Herstellung überwacht. Die Quantifizierung erfordert üblicherweise LC-MS/MS, LC-UV mit orthogonaler Bestätigung und gelegentlich HRMS zur Abtrennung von verwandten Amin-Spezies im Rahmen von Impuritätskontrollstrategien nach ICH Q3A und M7.
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