Clonidine EP Impurity C (2 | 6-dicloroanilina | CAS 608-31-1) es una impureza orgánica crítica en el control de calidad del clonidina. Su estructura aromática con dos átomos de cloro altera el perfil de pureza y puede influir en la seguridad farmacéutica. Se detecta y cuantifica mediante HPLC con detección UV | GC-MS para confirmación y RMN para caracterización estructural. Esta impureza suele generarse por rutas de síntesis incompletas o degradación de intermediarios por exposición a calor o humedad | por lo que su monitoreo es esencial para cumplir la monografía EP. Se recomiendan condiciones de almacenamiento frescas y secas y procedimientos de síntesis optimizados para minimizar su presencia.
Referencias
Zhao, Xu, et al. “Electro-Oxidation of Diclofenac at Boron Doped Diamond: Kinetics and Mechanism.” Electrochimica Acta, vol. 54, no. 17, July 2009, pp. 4172–79, https://doi.org/10.1016/j.electacta.2009.02.059. ?Todd, Peter A., and Eugene M. Sorkin. “Diclofenac Sodium.” Drugs, vol. 35, no. 3, Mar. 1988, pp. 244–85, https://doi.org/10.2165/00003495-198835030-00004.
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