O-Desphenyl O-methyl Sofosbuvir es una impureza identificada en el proceso de síntesis de Sofosbuvir | notable por su presencia en etapas de reacción y purificación. Su detección requiere métodos analíticos robustos como HPLC con detección UV | LC-MS para confirmación de masa y | cuando procede | RMN para elucidación estructural. El perfil de impurezas debe ser controlado mediante especificaciones y límites de aceptación | con estrategias de mitigación que incluyen optimización de condiciones de reacción | control de materias primas y purificación cromatográfica. La evaluación de estabilidad y riesgo genotóxico forma parte del aseguramiento de calidad para asegurar que la impureza no exceda niveles aceptables.
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