Leflunomide BP Impurity E; Teriflunomide Isoxazole Impurity; 3-Methyl-N-[4-(trifluoromethyl)phenyl]-4-isoxazolecarboxamide;
Descripción
Leflunomide EP Impurity E (CAS 208401-20-1) es una impureza isoxazólica identificada durante la síntesis y el control de calidad de leflunomida. Conocida también como Leflunomide BP Impurity E | Teriflunomide Isoxazole Impurity o 3-Methyl-N-[4-(trifluoromethyl)phenyl]-4-isoxazolecarboxamide | presenta el núcleo isoxazol y el sustituyente trifluorometil que afectan polaridad y estabilidad. Requiere identificación y cuantificación por HPLC y LC-MS para evaluar su impacto en la pureza del API | diseño de procesos y especificaciones. Su control incluye optimización de condiciones de reacción | pasos de purificación y pruebas de degradación forzada para garantizar cumplimiento farmacopéutico y límites aceptables.
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