N-Nitroso Eltrombopag es una impureza nitrosamina identificada en el perfil de impurezas de Eltrombopag que requiere evaluación rigurosa por su potencial genotóxico. La caracterización analítica mediante LC-MS/MS y GC-MS con trazabilidad de métodos validados permite detección a niveles muy bajos y soporte para estudios de estabilidad y origen por nitrosación de precursores amínicos. Las estrategias de control de calidad incluyen evaluación toxicológica conforme a las guías regulatorias ICH M7 | establecimiento de límites aceptables | monitoreo de procesos y medidas de mitigación para minimizar formación durante síntesis y almacenamiento. Información sobre perfil | pureza y pruebas de lote es esencial para cumplimiento regulatorio.
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