Amfenac Ethyl Ester (CAS 61941-57-9) es una impureza de síntesis identificada en procesos de producción de derivados carboxílicos. Su estructura éster confiere mayor lipofilicidad y susceptibilidad a hidrólisis a ácido correspondiente | afectando el perfil de pureza y la estabilidad del lote. Se detecta y cuantifica mediante métodos validados como HPLC-UV y LC-MS con muestreo de fase reversa y condiciones indicadoras de degradación. El control analítico incluye límites de especificación basados en evaluación de seguridad | evaluación de la formación durante reacciones y controles de proceso como purificación por cromatografía y ajuste de condiciones de secado. Monitorizar esta impureza reduce riesgos regulatorios y variabilidad del producto.
Referencias
Yanni, Susan E., et al. “The Effects of Nepafenac and Amfenac on Retinal Angiogenesis.†Brain Research Bulletin, vol. 81, no. 2-3, Feb. 2010, pp. 310–319, 10.1016/j.brainresbull.2009.10.018.
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