Impureza de darolutamida 4 es un degradado estructural identificado durante el desarrollo y escalado del principio activo. Su caracterización mediante LC-MS | NMR y HPLC es esencial para definir su masa exacta | patrones de fragmentación y tiempos de retención relativos. Se recomienda evaluar su formación bajo estrés térmico | húmedo y fotolítico | así como su comportamiento en etapas de síntesis y purificación para establecer límites de aceptación y procedimientos de remoción. Impacta en la pureza del lote y puede requerir controles de proceso | criterios de limpieza y estudios de toxicidad para cumplir requisitos regulatorios. La implementación de métodos analíticos validados asegura monitorización y cumplimiento del perfil de impurezas.
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