Nilotinib EP Impurity H, auch als Nilotinib Regio Isomer Impurity bezeichnet, ist ein Stellungsisomer des pyrimidylsubstituierten Kinaseinhibitors Nilotinib und wird mit alternativen Arylierungs- oder Cyclisierungswegen während der Synthese assoziiert. Es handelt sich nicht um einen einfachen Abbauprodukt, sondern um eine strukturell verwandte Prozessverunreinigung, die eine orthogonale Identifizierung erfordert. CAS 641571-15-5 entspricht C28H22F3N7O mit einer Molekülmasse von 529,52 g/mol. Da Regioisomere in konventioneller HPLC mit dem Wirkstoff koeluieren können, stützt sich die Charakterisierung typischerweise auf LC-MS/MS, hochauflösende MS und NMR. Die Substanz unterliegt den Spezifikationsanforderungen für Verunreinigungen und toxikologischer Bewertung.
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 Hughes, Timothy, et al. “Impact of Baseline BCR-ABL Mutations on Response to Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase.” Journal of Clinical Oncology, vol. 27, no. 25, Sept. 2009, pp. 4204–10
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