Ethyl 5-Methylisoxazole-4-carboxylate (CAS 51135-73-0) es una impureza heteroaromática que puede formarse por reacciones secundarias o por incompleta esterificación durante la síntesis de compuestos isoxazolados; su presencia afecta la pureza y la reproducibilidad del proceso debido a su reactividad potencial hacia hidrólisis y transesterificación. La detección y cuantificación se realiza mediante HPLC | LC-MS | GC-MS y RMN para confirmar identidad y niveles residuales. Las medidas de control incluyen optimización de condiciones de reacción | purificación por cromatografía preparativa o recristalización y monitoreo continuo en control de calidad para minimizar impactos en rendimiento y seguridad del producto final.
Referencias
Elsevier. “Structures of Leflunomide and Its Pharmacopoeial Impurities.†ResearchGate, ResearchGate, Oct. 2014, www.researchgate.net/figure/Structures-of-leflunomide-and-its-pharmacopoeial-impurities_fig3_267274939. ‌
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