Impureza Aceclofenac EP Impurity G (CAS 1215709-75-3) es un degradado y subproducto de síntesis asociado al principio activo aceclofenac | descrito también como Acetic Aceclofenac y Carboxymethyl Aceclofenac entre otros sinónimos. Su identificación y cuantificación son esenciales para el cumplimiento de monografías EP y para garantizar la seguridad del producto | utilizando técnicas analíticas como HPLC con detección UV y confirmación por LC-MS/MS. La detección de esta impureza puede revelar rutas de degradación por hidrólisis o reacción con agentes acetilantes | por lo que se recomienda establecer límites especificados | estudios de estabilidad y procedimientos de purificación robustos.
Referencias
Karbhari, PradnyaA, et al. “RP-LC Gradient Elution Method for Simultaneous Determination of Thiocolchicoside, Aceclofenac and Related Impurities in Tablet Formulation.â€Â 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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