Salcaprozate Impurity 2 (CAS 2037-95-8) é uma impureza heterocíclica identificada como 1 | 3-benzoxazine-2 | 4-diona | também registrada como 4H-1 | 3-benzoxazine-2 | 4(3H)-diona e 3 | 4-dihidro-2H-1 | 3-benzoxazine-2 | 4-diona. Essa impureza apresenta propriedades físico-químicas que exigem monitoramento em controle de qualidade | sendo detectável por HPLC com padrões de retenção específicos e confirmável por NMR | espectrometria de massas e análise por infravermelho. Informação sobre perfil de pureza | limites de especificação e possíveis vias de formação durante síntese são essenciais para avaliação do risco e estabelecimento de estratégias analíticas robustas para eliminação e quantificação dessa impureza.
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