2-(2-(2-(2-(2-(2,6-Dichlorophenylamino)phenyl)-acetoxy)acetoxy)acetoxy)acetic acid; Benzeneacetic acid, 2-((2,6-dichlorophenyl)amino)-, 2-(2-(carboxymethoxy)-2-oxoethoxy)-2-oxoethyl ester; Aceclofenac Impurity H
Descripción
Impureza Aceclofenac EP H (CAS 1216495-92-9) | también conocida como Diacetic Aceclofenac | es un derivado diacético de la molécula madre cuya presencia requiere control riguroso en procesos farmacéuticos; su estructura poliéster aumenta polaridad relativa y puede alterar retención en HPLC | por lo que su identificación por LC-MS y confirmación por espectroscopía NMR son esenciales. Esta impureza puede originarse por reacciones de acetilación o transesterificación durante síntesis o almacenamiento | impactando pureza y perfiles de degradación. La cuantificación precisa y la especificación según EP permiten gestionar riesgos de calidad y asegurar cumplimiento analítico en lotes de aceclofenac.
Referencias
Karbhari, PradnyaA, et al. “RP-LC Gradient Elution Method for Simultaneous Determination of Thiocolchicoside, Aceclofenac and Related Impurities in Tablet Formulation.” Journal of Pharmacy and Bioallied Sciences, vol. 6, no. 4, 2014, p. 246, https://doi.org/10.4103/0975-7406.142955. Dooley, Mukta, et al. “Aceclofenac.” Drugs, vol. 61, no. 9, 2001, pp. 1351–78, https://doi.org/10.2165/00003495-200161090-00012. ?
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