Dinitroso Palbociclib, auch als Palbociclib Nitroso Impurity 2 bezeichnet, ist eine nitrosoabgeleitete prozessbezogene Verunreinigung des Palbociclib-Gerüsts und weist funktionelle Merkmale nitrosaminähnlicher Spezies auf. Mit der Summenformel C24H27N9O4 und einer Molekülmasse von 505.05 g/mol handelt es sich um ein klar definiertes Produkt von Nitrosierung und Oxidation, das während der Synthese oder unter nitrosierenden Bedingungen aus aminhaltigen Vorstufen entstehen kann. Solche Verbindungen werden im Rahmen von ICH M7 hinsichtlich möglicher mutagener Risiken bewertet. Der Nachweis im Spurenbereich erfordert üblicherweise LC-MS/MS, hochauflösende LC-MS und gegebenenfalls bestätigende GC-MS-Methoden.
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