Aceclofenac EP Impurity C (CAS 15307-77-4) | también referida como Aceclofenac Impurity C o Aceclofenac BP Impurity C y como Diclofenac Ethyl Ester | ethyl 2-[2-(2 | 6-dichloroanilino)phenyl]acetate | es un producto relacionado crítico en el control de calidad de aceclofenaco. Esta impureza orgánica clorada presenta características fisicoquímicas definidas que afectan el perfil de pureza y deben ser cuantificadas por HPLC con detección UV y confirmadas por LC-MS y NMR. Su monitorización es esencial para cumplimiento de límites según ICH y monografías EP y BP | estableciendo criterios de aceptación | procedimientos de muestreo y estrategias de eliminación en procesos sintéticos. Se suministra con certificado de análisis y especificaciones trazables.
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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