Nilotinib impureza G es un subproducto químico identificado como Methyl 4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzoic Acid Ester | relevante en el perfil de impurezas del proceso de síntesis de Nilotinib. Desde un punto de vista técnico se caracteriza por su naturaleza éster y porportarse como impureza derivada de reacciones de esterificación o incompleta hidrólisis; su detección y cuantificación requieren técnicas analíticas como HPLC con detección por UV | espectrometría de masas y NMR para confirmación estructural. Su presencia puede afectar estabilidad y cumplimiento de especificaciones | por lo que se recomienda establecer límites de aceptación | estrategias de purificación cromatográfica y controles in‑process para minimizar su formación.
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.?Cho, Jin Hyun, et al. “Nilotinib in Patients with Metastatic Melanoma Harboring KIT Gene Aberration.” Investigational New Drugs, vol. 30, no. 5, Nov. 2011, pp. 2008–14, https://doi.org/10.1007/s10637-011-9763-9.?
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