Impureza 9 de Eltrombopag (trifluoroacetato) es una impureza relacionada generada durante procesos sintéticos o de purificación que incorpora un ion trifluoroacetato y altera las propiedades fisicoquímicas respecto al ingrediente activo. Se identifica mediante perfiles cromatográficos y espectrométricos | con tiempo de retención característico en HPLC y evidencias por LC-MS y NMR | lo que facilita su cuantificación en controles de calidad. Su presencia puede influir en la estabilidad y en los patrones de degradación del lote por lo que requiere estrategias de control robustas | límites de aceptación definidos | métodos analíticos validados y estudios de estrés para garantizar la conformidad regulatoria.
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