A Acetyl Empagliflozin Furanose Impurity é um análogo relacionado ao processo e/ou à degradação da empagliflozina, definido pela O-acetilação do arcabouço glicosídico derivado de furanose. Com fórmula molecular C31H35ClO11 e massa molecular de 619.05 g/mol, preserva o núcleo aril clorado do tipo C-glicosídeo e incorpora uma função acetato adicional, que pode surgir por desproteção incompleta, transferência de acetila ou transformação subsequente de intermediários protegidos. A avaliação estrutural é pertinente ao perfil de impurezas segundo ICH Q3A/Q3B. A quantificação em nível traço geralmente requer LC-MS/MS ou LC-MS de alta resolução, complementada por HPLC-UV ortogonal ou caracterização por RMN para discriminação de isômeros.
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