A Impureza EP F do nilotinibe, também denominada análogo etilimidazol de nilotinibe, é uma impureza de प्रक्रिया estruturalmente relacionada ao inibidor de tirosina quinase BCR-ABL nilotinibe. Trata-se de um derivado imidazólico alquilado, tipicamente associado ao desenvolvimento da rota sintética ou à formação incompleta do heterociclo, e não de um simples degradante. Com CAS 2119583-24-1, fórmula molecular C29H24F3N7O e massa molecular de 543.54 g/mol, requer caracterização ortogonal por LC-MS/MS, MS de alta resolução e HPLC para perfil de impurezas, com confirmação por RMN quando isolável. Sua avaliação se insere nas exigências de controle de impurezas da ICH Q3A e especificações regulatórias correlatas.
Referências
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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