Amisulpride EP Impurity G (CAS 148516-68-1) es una impureza identificada en el perfil de degradación y síntesis de amisulprida que requiere vigilancia analítica en procesos farmacéuticos. Se caracteriza mediante técnicas cromatográficas y espectrométricas | incluyendo HPLC con detección UV y espectrometría de masas para determinación de masa exacta y fragmentación. Su evaluación comprende parámetros de identidad | cuantificación | límites de aceptación y estabilidad bajo estrés. El control de esta impureza es crítico para cumplir especificaciones EP y normativas | minimizando riesgos de toxicidad y garantizando consistencia de lote a lote. Proveemos datos analíticos y criterios de aceptación para apoyo en liberación de materia prima.
Referencias
Coukell, Allan J., et al. “Amisulpride.†CNS Drugs, vol. 6, no. 3, Sept. 1996, pp. 237–56, https://doi.org/10.2165/00023210-199606030-00006.
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