La Impureza EP F de nilotinib, también denominada análogo etilimidazol de nilotinib, es una impureza de proceso estructuralmente relacionada con el inhibidor de la tirosina cinasa BCR-ABL nilotinib. Corresponde a un derivado imidazólico alquilado que suele originarse en el desarrollo de la ruta sintética o por construcción incompleta del heterociclo, más que por una simple degradación. Con CAS 2119583-24-1, fórmula molecular C29H24F3N7O y peso molecular 543.54 g/mol, exige caracterización ortogonal mediante LC-MS/MS, MS de alta resolución y HPLC de perfil de impurezas, con confirmación por RMN cuando es aislable. Su evaluación se enmarca en ICH Q3A y especificaciones regulatorias conexas.
Referencias
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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