Eltrombopag Impurity 28 (Trifluoroacetate) es una impureza relacionada que aparece como aducto trifluoroacetato en procesos de síntesis y purificación de eltrombopag; requiere identificación y cuantificación precisas para garantizar la calidad del API. Su monitorización se realiza típicamente por HPLC y LC-MS | donde muestra un desplazamiento de retención y un aumento de masa consistente con el aducto trifluoroacetato | y su confirmación estructural se obtiene mediante RMN y HRMS. La presencia de esta impureza puede influir en la estabilidad | perfil de degradación y especificaciones del producto | por lo que su control en etapas de síntesis y formulación y la definición de límites de aceptación documentados son esenciales para el cumplimiento regulatorio.
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