Informações adicionais sobre o Empagliflozin Impurity 52 (Mixture of Diastereomers)
Fármaco de origem
Empagliflozin
Nome IUPAC
2-(((S)-tetrahydrofuran-3-yl)oxy)tetrahydrofuran
Sinônimos
N/A
Descrição
Impureza de Empagliflozina 52 consiste em uma mistura de diastereômeros observada durante síntese ou armazenamento do ativo. Esta impureza apresenta variações estereoquímicas que afetam propriedades físico-químicas e perfil de impurezas | exigindo caracterização por HPLC com fase reversa e cromatografia quiral | LC-MS para massa molecular e NMR para estabelecimento de configuração relativa. A presença desta mistura pode indicar rotas de reação concorrentes ou epimerização e deve ser monitorada com limites de especificação e estratégia de controle conforme diretrizes ICH sobre impurezas. Métodos analíticos validados e estudos de estabilidade são essenciais para quantificar e controlar esta entidade estereoquímica.
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