Eltrombopag Impurity 3 | CAS: 1437383-35-1 | es una impureza relacionada observada en el proceso de síntesis y purificación de eltrombopag. Su perfil analítico se determina por HPLC y LC-MS con confirmación por RMN e IR | mostrando retención y patrones de fragmentación distintos al compuesto principal. Se investiga su origen por rutas de reacción secundarias y transformaciones durante steps de protección/desprotección y condiciones de temperatura o pH. La impureza puede afectar la pureza y estabilidad del lote por lo que se establecen límites de especificación conforme a guías ICH | y se controlan mediante optimización de condiciones de reacción | cromatografía preparativa y monitoreo en proceso.
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