Impureza 3 de bromfenac (CAS 136266-79-0) es un subproducto sintético identificado durante la síntesis y degradación del bromfenac. Su caracterización incluye fórmula empírica | masa molecular y análisis por LC-MS | RMN y HPLC con tiempo de retención reproducible. Presenta propiedades físicoquímicas relevantes para control de calidad como solubilidad limitada en disolventes orgánicos | punto de fusión definido y potenciales productos de degradación térmica. Su perfil de impurezas requiere límites analíticos | procedimientos de cuantificación validados y evaluación toxicológica comparativa frente al API. El seguimiento de esta impureza garantiza cumplimiento de especificaciones y soporte regulatorio en liberación de lotes.
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