Impureza Eltrombopag 41 (trifluoroacetato) es un subproducto analítico relevante en el control de calidad del proceso sintético de eltrombopag; se caracteriza por su adición de trifluoroacetato detectable por LC-MS mediante un tiempo de retención y espectro de masas específicos | y por un patrón de fragmentación reproducible en espectrometría de masas de alta resolución. Su presencia puede afectar el perfil de pureza y estabilidad del lote | por lo que se requiere identificación confirmatoria por LC-UV | LC-MS/MS y | cuando procede | RMN. El control incluye límites de aceptación basados en ICH Q3A/Q3B | métodos validados | procedimientos de remoción de trifluoroacetato y estándares de referencia para cuantificación precisa.
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