Impureza de Abemaciclib Mesylate (CAS 1231930-82-7) caracterizada por especies relacionadas estructuralmente como desmetilados | isómeros posicionales | dessulfonatos | N-óxidos y subproductos procedentes del fragmento piperazínico; estas impurezas se generan durante la síntesis | la purificación o por degradación inducida por humedad | calor u oxidantes y requieren un perfil de impurezas robusto para garantizar la calidad del material. La identificación y cuantificación se realiza mediante HPLC con detección UV | LC-MS y NMR para establecer límites de aceptación. Su control incluye optimización de condiciones de reacción | etapas de lavado y cromatografía | estudios de estabilidad forzada y cumplimiento de guías ICH Q3A/Q3B para definir especificaciones analíticas.
Referencias
Kim, Esther S. “Abemaciclib: First Global Approval.” Drugs, vol. 77, no. 18, Nov. 2017, pp. 2063–70, https://doi.org/10.1007/s40265-017-0840-z.
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