Nilotinib EP Impurity H, designada también Nilotinib Regio Isomer Impurity, es un isómero posicional del inhibidor de quinasa nilotinib con sustitución pirimidínica, asociado a rutas alternativas de arilación o ciclación durante la síntesis. No constituye un degradante simple, sino una impureza de proceso estructuralmente relacionada que requiere identificación ortogonal. El CAS 641571-15-5 corresponde a C28H22F3N7O, con peso molecular de 529.52 g/mol. Dado que los regioisómeros pueden coeluir con el compuesto padre en HPLC convencional, su caracterización suele depender de LC-MS/MS, MS de alta resolución y confirmación por RMN. Su presencia se evalúa bajo marcos de especificación de impurezas y calificación toxicológica.
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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