La impureza Eltrombopag Impurity 38 (CAS 1428987-69-2) es un componente crítico del perfil de impurezas en el desarrollo y control de calidad de Eltrombopag. Su monitorización mediante HPLC-UV y LC-MS permite identificación y cuantificación precisas; NMR complementa la elucidación estructural. Su presencia puede afectar la estabilidad del lote y los límites deben establecerse de acuerdo con ICH Q3A y evaluación de riesgo toxicológico. Se recomienda validar métodos analíticos para límite de detección y cuantificación | determinar tiempo de retención y respuesta relativa | y documentar procedimientos de eliminación durante purificación y escalado.
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