Impureza Aceclofenac EP Impurity D (CAS 139272-66-5) | conocida también como Aceclofenac Methyl Ester o Methyl Aceclofenac | es un derivado éster del principio activo que puede formarse por esterificación incompleta o transesterificación durante la síntesis o el almacenamiento; desde el punto de vista analítico requiere identificación y cuantificación precisas mediante HPLC con detección UV | LC-MS y confirmación estructural por RMN. Su control es crítico para cumplir especificaciones de la Farmacopea Europea | evaluar límites de aceptación y estudiar su perfil de degradación y extracción para una gestión de calidad robusta.
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. Brogden, Rex N., and Lynda R. Wiseman. “Aceclofenac.” Drugs, vol. 52, no. 1, July 1996, pp. 113–24, https://doi.org/10.2165/00003495-199652010-00008. ?
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