Amfenac Glucuronide | también denominado Amfenac Acyl-β-D-Glucuronide | es una impureza metabolítica relevante en el control de calidad de materias primas y formulaciones que contienen amfenac. Presenta propiedades fisicoquímicas y de polaridad que afectan la retención en cromatografía líquida y requiere métodos validados de HPLC y LC-MS para su identificación y cuantificación. La presencia de este glucurónido influye en el perfil de impurezas | límites de especificación y estudios de estabilidad | y su cuantificación precisa es crítica para garantizar la seguridad y cumplimiento regulatorio. Se recomiendan procedimientos de preparación de muestras y técnicas de ionización optimizadas para análisis reproducibles.
Referencias
Chastain, James E., et al. “Distribution of Topical Ocular Nepafenac and Its Active Metabolite Amfenac to the Posterior Segment of the Eye.†Experimental Eye Research, vol. 145, 1 Apr. 2016, pp. 58–67, www.sciencedirect.com/science/article/pii/S0014483515300464, 10.1016/j.exer.2015.10.009. Accessed 31 Jan. 2022.
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