Ethyl 5-Methylisoxazole-4-carboxylate (CAS 51135-73-0) é uma impureza heterocíclica frequentemente monitorada em matérias-primas e intermediários devido ao seu potencial impacto no perfil de pureza e nas propriedades fisicoquímicas do produto final. Caracteriza-se por massa molecular e sinais específicos por espectrometria de massas e ressonância magnética nuclear | e é detectável por técnicas cromatográficas como HPLC e GC acopladas a detectores espectrométricos. A presença desta impureza pode afetar rendimento analítico | estabilidade e requisitos de segurança | exigindo estratégias de controle analítico e limites de especificação baseados em estudos de risco e toxicidade. Fornece dados críticos para conformidade regulatória e garantia de qualidade.
Referências
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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