2-(2-amino-3-benzoylphenyl)-2-oxoacetic acid, sodium salt
Sinónimos
N/A
Descripción
Impureza relacionada con Bromfenac | identificada como Bromfenac Impurity 7 (CAS 126849-31-8) | es una impureza de proceso que puede formarse durante la síntesis o la degradación del principio activo; su control es crítico para garantizar la calidad farmacéutica. Caracterizada mediante técnicas analíticas avanzadas como HPLC con detección UV | espectrometría de masas (MS) y resonancia magnética nuclear (NMR) | su presencia puede alterar el perfil de pureza y estabilidad del lote. La implementación de límites especificados | validación de métodos cuantitativos | estudios de degradación forzada y estrategias de purificación permite mitigar su impacto y cumplir requisitos regulatorios.
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