La impureza 111 de Brexpiprazol es un subproducto observado en etapas de síntesis y en estudios de degradación que requiere inspección analítica detallada para su identificación y control. Su caracterización incluye determinación de masa exacta por LC-MS | perfil de fragmentación | espectros UV y comportamiento de retención en HPLC para desarrollar métodos de cuantificación selectiva. Su evaluación se realiza conforme a directrices ICH para identificación | calificación y límites de aceptación | y se aborda mediante optimización de condiciones de reacción | pasos de purificación y controles en proceso. El conocimiento físico-químico y la evaluación toxicológica son esenciales para gestionar el riesgo regulatorio y asegurar la calidad del lote.
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