Impureza isomérica E de Sacubitril Maleic Acid representa una variante estructural crítica que puede afectar el perfil de pureza y la estabilidad del lote final. Esta impureza origina por inversión geométrica durante la síntesis o condiciones de almacenamiento y dificulta la separación cromatográfica cuando coeluye con el isómero deseado. Requiere técnicas analíticas robustas como HPLC con gradiente optimizado | LC-MS y NMR para identificación y cuantificación precisa. Desde el punto de vista regulatorio es importante establecer límites basados en ICH Q3A y validar métodos de control mediante estándares crudos | estrategias de recristalización y control de pH para minimizar su formación y asegurar cumplimiento de especificaciones.
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