El metabolito M4 de Alectinib (CAS 1256585-04-2) se caracteriza como una impureza de proceso y degradación con relevancia en el perfil de impurezas del principio activo. Su identificación y cuantificación requieren técnicas analíticas robustas como LC-MS | HPLC con detección UV y RMN para confirmar estructura y pureza. La presencia de M4 puede derivar de rutas sintéticas comunes y de metabolismo in vitro | por lo que es clave definir límites especificados conforme a ICH Q3A/Q3B y establecer procedimientos de control y remediación en escalado. Estudios de estabilidad | pruebas de material de referencia y validación analítica garantizan trazabilidad y cumplimiento regulatorio.
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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