Valproic Acid EP Impurity A (CAS 109-52-4) es una impureza orgánica relacionada con el ácido valproico que puede generarse durante la síntesis | purificación o por degradación térmica y oxidativa del principio activo. Su control es esencial en el aseguramiento de la calidad | empleando HPLC-UV para cuantificación | LC-MS para confirmación estructural y métodos validados conforme a ICH Q2(R1). La impureza puede alterar la pureza | estabilidad y perfil de seguridad del producto final | por lo que la Farmacopea Europea establece límites y criterios de aceptación. Se recomiendan estrategias de control en materia prima | optimización de procesos y limpieza para minimizar su formación.
Referencias
Reddy, S. Raghavender, et al. “Reliable GC Method for Related Substances in Divalproex Sodium Drug.” Journal of Chromatographic Science, vol. 55, no. 9, July 2017, pp. 891–98, https://doi.org/10.1093/chromsci/bmx057. ?
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