Dapagliflozin Hydroxy (CAS 960404-86-8) é uma impureza hidroxilada frequentemente observada no processo de síntese e no armazenamento do princípio ativo dapagliflozin. Estruturalmente caracterizada pela adição de um grupo hidroxila | sua presença indica vias de oxidação ou reações secundárias durante etapas de reação e purificação. A detecção e quantificação são realizadas por HPLC acoplado a LC-MS | com confirmação por RMN. Do ponto de vista de controle de qualidade | exige monitoramento sistemático | estabelecimento de limites conforme ICH e medidas de mitigação como atmosfera inerte | agentes redutores e otimização de etapas cromatográficas para garantir conformidade de estabilidade e segurança do lote.
Referências
“Dapagliflozin: MedlinePlus Drug Information.†Medlineplus.gov, Feb. 2022, medlineplus.gov/druginfo/meds/a614015.html.
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