Leflunomide Impurity G; Leflunomide BP Impurity G; 5-Methyl-N-(p-tolyl)isoxazole-4-carboxamide; 5-Methyl-N-(4-methylphenyl)-4-isoxazolecarboxamide; Leflunomide EP Impurity G
Descripción
Impureza Leflunomide EP Impurity G (CAS 724429-16-7) | también denominada 5-Methyl-N-(p-tolyl)isoxazole-4-carboxamide o 5-Methyl-N-(4-methylphenyl)-4-isoxazolecarboxamide | es un degradado sintético relevante en el control de calidad del leflunomida. Se caracteriza por su fórmula y características cromatográficas y espectrométricas | y requiere identificación por HPLC con detección UV y confirmación por LC-MS y RMN. Su presencia puede indicar rutas laterales de reacción o condiciones de reacción subóptimas | por lo que se establecen límites de especificación | estudios de estabilidad y procedimientos de reducción en proceso. La cuantificación precisa y la calificación toxicológica son esenciales para cumplimiento regulatorio y asegura la calidad del principio activo.
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