3-Bromo Bromfenac Isomer es una impureza estructural que puede formarse durante la síntesis o el almacenamiento de bromfenac | caracterizada por un posicionamiento alternativo del sustituyente bromo en el núcleo aromático. Su presencia afecta el perfil de impurezas del principio activo | por lo que requiere identificación y cuantificación mediante técnicas analíticas robustas como HPLC con detección UV | espectrometría de masas y RMN. Se investigan rutas de formación | condiciones de reacción y factores de degradación para definir límites de especificación y estrategias de control en el desarrollo farmacéutico. El conocimiento de su espectro y propiedades fisicoquímicas facilita la mitigación del riesgo y el cumplimiento regulatorio.
Referencias
Rovere, Giuseppe, et al. “Topical Treatment with Bromfenac Reduces Retinal Gliosis and Inflammation after Optic Nerve Crush.†Investigative Opthalmology & Visual Science, vol. 57, no. 14, Nov. 2016, p. 6098, https://doi.org/10.1167/iovs.16-20425
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