Nilotinib EP Impurity E, también denominada Desmethylimidazole Nilotinib, es una impureza de proceso definida del inhibidor de cinasas nilotinib, formada por desalquilación sintética o por formación incompleta del heterociclo durante una ruta de fabricación específica. Está identificada por CAS 2119583-26-3 y presenta fórmula molecular C27H20F3N7O, con un peso molecular de 515.49 g/mol. Conserva el núcleo 2-fenilamino pirimidina y el motivo imidazólico, pero con un patrón de N-alquilación distinto al del principio activo. Su caracterización suele requerir LC-MS/MS, espectrometría de masas de alta resolución y perfiles ortogonales por HPLC, además de RMN para confirmación estructural en el contexto farmacopéico e ICH.
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.?
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