Informações adicionais sobre o (R)-tetrahydrofuran-3-yl 4-nitrobenzenesulfonate
Fármaco de origem
Empagliflozin
Nome IUPAC
(R)-tetrahydrofuran-3-yl 4-nitrobenzenesulfonate
Sinônimos
N/A
Descrição
Impureza (R)-tetrahydrofuran-3-yl 4-nitrobenzenesulfonate é um subproduto ópticamente ativo com massa molecular definida que surge em rotas de sulfonatação de intermediários alcoólicos; apresenta retenção característica em cromatografia reversa e é identificável por espectrometria de massa e 1H NMR | com sinais distintos no anel nitro e no anel oxetano. Esta impureza pode alterar rendimento e propriedades físico químicas do lote | exigindo medidas de controle como ajuste de pH | etapas de purificação cromatográfica e monitorização por HPLC quiral para avaliar teor enantiomérico. Estudos de estabilidade e limites de especificação são recomendados para gestão de risco no controle de qualidade.
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