Nilotinib EP Impurity E, auch als Desmethylimidazole Nilotinib bezeichnet, ist eine definierte verfahrensbedingte Verunreinigung des Kinaseinhibitors Nilotinib und entsteht typischerweise durch synthetische Desalkylierung oder unvollständige Heterozyklusbildung während der herstellungsabhängigen Route. Die Substanz ist unter CAS 2119583-26-3 registriert und besitzt die Summenformel C27H20F3N7O bei einer Molekülmasse von 515,49 g/mol. Strukturell bleibt das 2-Phenylamino-Pyrimidin-Gerüst mit Imidazol-Motiv erhalten, jedoch mit veränderter N-Alkylierung gegenüber dem Wirkstoff. Für Identifizierung und Gehaltsbestimmung sind LC-MS/MS, hochauflösende Massenspektrometrie und orthogonale HPLC-Impurity-Profile üblich, ergänzt durch NMR zur Strukturabsicherung.
References
Kondra, S. B., et al. “A Validated Stability-Indicative UPLC Method for Nilotinib Hydrochloride for the Determination of Process-Related and Degradation Impurities.” Journal of Chromatographic Science, vol. 52, no. 8, Sept. 2013, pp. 880–85, https://doi.org/10.1093/chromsci/bmt134.?
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