Brexpiprazole Impurity 130 es una impureza relacionada identificada durante el desarrollo y control de calidad de brexpiprazol | relevante por su perfil de degradación y posibles efectos en la pureza del lote. Se caracteriza mediante técnicas analíticas avanzadas como HPLC con detección UV | LC-MS y espectroscopía NMR para determinar estructura | masa molecular y comportamiento cromatográfico. Su cuantificación y límites se establecen conforme a directrices ICH para sustancias relacionadas y producto terminado | integrando estudios de estabilidad y estrés para definir criterios de aceptación y procedimientos de eliminación en procesos sintéticos y purificación | asegurando trazabilidad analítica y cumplimiento regulatorio.
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