La impureza G de bicalutamida es un degradado relacionado identificado durante estudios de estabilidad y síntesis que afecta al perfil de pureza del principio activo. Presenta propiedades fisicoquímicas distintivas que requieren cuantificación mediante métodos analíticos validados como HPLC acoplado a detectores UV y LC-MS para confirmación estructural | apoyada por RMN cuando es posible. Su monitoreo es crítico para cumplir especificaciones y guías regulatorias de impurezas orgánicas | determinando límites de aceptación y estrategias de control en procesos y formulaciones. Se recomienda evaluación de su vía de formación | pruebas de estrés y establecimiento de límites basados en evaluación toxicológica y de exposición.
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