Impureza Bromfenac sodium Impurity-E es un degradante identificado durante la síntesis y el almacenamiento de bromfenaco sódico. La caracterización estructural mediante LC-MS | RMN y HPLC analítica permite definir su masa exacta | patrones de fragmentación y retención cromatográfica | facilitando su cuantificación en procesos de control de calidad. Su presencia puede afectar estabilidad | pureza y cumplimiento de especificaciones | por lo que se implementan límites de aceptación y estudios de estrés para entender su formación y vías de degradación. La disponibilidad de un estándar de referencia y métodos validados es esencial para la monitorización | desarrollo de procesos y mitigación del riesgo en producción farmacéutica.
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