La Impureza II de Clonidina (Clonidine Impurity II | CAS 21709-18-2) | conocida también como 2 | 6-dichlorophenyl carbonimidic dichloride | es un contaminante de proceso identificado por su estructura halogenada y su reactividad acilante. Se caracteriza por solubilidad limitada en disolventes polares y señales cromatográficas discretas que facilitan su identificación por HPLC con detección UV y confirmación por LC-MS o GC-MS. La presencia de esta impureza afecta las especificaciones de pureza farmacéutica y exige límites analíticos definidos y estrategias de control mediante optimización de síntesis | purificación y ensayos de estabilidad. Su cuantificación exacta es crítica para cumplimiento regulatorio y seguridad del producto.
Referencias
Lowenthal, D. T., et al. “Clinical Pharmacokinetics of Clonidine.†Clinical Pharmacokinetics, vol. 14, no. 5, May 1988, pp. 287–310, https://doi.org/10.2165/00003088-198814050-00002. ?
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