Nilotinib Impurity 1 es una impureza conocida del compuesto activo nilotinib | relevante en el control de calidad por su impacto potencial en la seguridad y eficacia del lote. Este analito se caracteriza por su estructura relacionada | propiedades fisicoquímicas y patrón cromatográfico distintivo en HPLC | permitiendo su identificación y cuantificación por técnicas de LC-MS | NMR y UV. La descripción incluye punto de fusión | solubilidad relativa y comportamiento de degradación bajo condiciones forzadas | facilitando el establecimiento de especificaciones y límites de aceptación. La monitorización rutinaria de Nilotinib Impurity 1 contribuye al cumplimiento regulatorio y a la robustez del perfil de impurezas del producto.
Referencias
Gopireddy, Ramana Reddy, and Arthanareeswari Maruthapillai. “A Stability Indicating Method Development and Validation for Separation of Process Related Impurities and Characterization of Unknown Impurities of Tyrosine Kinase Inhibitor Nilotinib by RP-HPLC, NMR Spectroscopy and ESI-MS.” Materials Today: Proceedings, vol. 40, 2021, pp. S127–38, https://doi.org/10.1016/j.matpr.2020.03.837.? Kondra, S. B., et al. “A
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