A impureza bromo de empagliflozina, CAS 915095-89-5, é uma impureza de processo halogenada associada à síntese de empagliflozina, compatível com um intermediário éter arílico bromado e clorado ou com subproduto residual decorrente de substituição incompleta ou arraste de reagentes. Sua composição, C17H16BrClO2, com peso molecular de 367,66 g/mol, descreve uma espécie neutra e lipofílica, cuja especificidade pode ser limitada em detecção UV convencional. A elucidação normalmente requer LC-MS/MS para confirmação de massa, complementada por HPLC-UV e técnicas ortogonais como RMN ou HRMS para definir a posição e excluir análogos isoméricos. Não é uma nitrosamina, mas permanece relevante no perfil de impurezas sob ICH Q3A.
Referências
“Empagliflozin: MedlinePlus Drug Information.†Medlineplus.gov, 2021, medlineplus.gov/druginfo/meds/a614043.html
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