2′-Alkene Mono-N-Benzoyl Sofosbuvir es una impureza estructural que incorpora una insaturación en la posición 2′ y un grupo N-benzoil mono protegido | típicamente generada como subproducto sintético o producto de degradación por eliminación y desprotección incompleta. Su mayor lipofilicidad y el cromóforo benzoyl modifican la retención cromatográfica y el perfil espectral | lo que facilita su identificación por HPLC-UV y confirmación por LC-MS/MS y RMN. La presencia de 2′-Alkene Mono-N-Benzoyl Sofosbuvir puede afectar la pureza y la estabilidad del lote | por lo que su cuantificación y control en etapas de proceso y estudios de estabilidad son críticos según lineamientos regulatorios. Se recomienda validar métodos analíticos específicos y establecer límites de especificación adecuados.
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