Benserazide EP Impurity A (Base libre) | CAS 64616-76-8 | es una impureza clave a controlar en el desarrollo y control de calidad de materias primas. Presenta propiedades físicoquímicas diferenciadas de la sal correspondiente | con solubilidad y perfil de ionización que afectan la separación cromatográfica. Su identificación y cuantificación se realizan por HPLC con detección UV y confirmación por espectrometría de masas | aplicando límites y criterios especificados en la Farmacopea Europea. La presencia de esta impureza puede influir en la pureza del API y en la estabilidad del lote por lo que se establecen métodos validados | criterios de aceptación y estrategias de eliminación en el proceso para garantizar conformidad regulatoria.
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