Brivaracetam Impurity 23 es una impureza relacionada estructuralmente con el principio activo que se detecta en el perfil de impurezas del proceso de síntesis. Su identificación se realiza mediante LC-MS y RMN bidimensional | complementada con HPLC para cuantificación y estudios de estabilidad | y su presencia puede indicar una vía secundaria de reacción o degradación. La caracterización incluye determinación de pureza | espectroscopía y evaluación de impurezas orgánicas volátiles cuando proceda. Su control es crítico para garantizar cumplimiento de límites analíticos y requisitos regulatorios | por lo que se recomiendan procedimientos de muestreo | métodos validados y límites de aceptación específicos en el lote farmacéutico.
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