Aceclofenac EP Impurity B | identificada como Diclofenac-methyl ester (CAS 15307-78-5) | es una impureza orgánica observada en procesos de síntesis y en estudios de estabilidad del aceclofenac; su presencia deriva típicamente de reacciones de esterificación o transesterificación y de degradación durante el procesamiento. Su naturaleza como metil éster altera la polaridad y el comportamiento cromatográfico | por lo que requiere métodos analíticos validados como HPLC con detección UV y técnicas de confirmación por LC-MS o GC-MS para identificación y cuantificación. El control riguroso de esta impureza es crítico para cumplir la monografía EP y los límites de impurezas relacionadas | garantizando la calidad y seguridad del producto farmacéutico.
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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