Olaparib Impurity 42 (CAS 763114-25-6) es una impureza relacionada con la molécula de olaparib que puede generarse por rutas sintéticas secundarias o por degradación durante el proceso de fabricación y almacenamiento; su identificación y cuantificación son críticas para el control de calidad. Esta impureza exige caracterización estructural por técnicas como LC-MS de alta resolución, RMN y métodos indicativos de estabilidad para definir su perfil cromatográfico y masa exacta. El control de Olaparib Impurity 42 se integra en la estrategia analítica conforme a ICH Q3A/Q3B mediante métodos indicativos de estabilidad validados, límites especificados y medidas de purificación e ingresos de material de referencia para garantizar cumplimiento regulatorio y seguridad del lote.
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