El metabolito Alectinib M1b constituye una impureza relevante en el control de calidad de lotes de Alectinib | identificada por técnicas cromatográficas y espectrometría de masas. Su presencia puede afectar el perfil de impurezas y la pureza química del principio activo | por lo que se recomienda su cuantificación mediante HPLC-UV y LC-MS/MS con métodos validados. Caracterizar su identidad | límites de aceptación y comportamiento en estudios de estabilidad es esencial para cumplir especificaciones regulatorias. Datos analíticos robustos | límites de detección y parámetros de validación garantizan un monitoreo eficiente | minimizando riesgos de desviaciones en el proceso y asegurando trazabilidad durante liberación de lote.
Referencias
Sato-Nakai, Mika, et al. “Metabolites of Alectinib in Human: Their Identification and Pharmacological Activity.â€Â Heliyon, vol. 3, no. 7, July 2017, p. e00354, https://doi.org/10.1016/j.heliyon.2017.e00354.
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