rac-trans-4-Hydroxy Glyburide (CAS 23155-04-6) | também referido como 4′-Hydroxyglibenclamide | é uma impureza relevante em perfis de qualidade de gliclazidas e glibenclamida; forma-se por metabolismo e degradação oxidativa e pode afetar potência e segurança do produto final. A sua monitorização é essencial via HPLC com detecção UV e confirmação por LC-MS em métodos validados conforme ICH Q2 | definindo limites de especificação e critérios de aceitação. Estudos de estabilidade e forçados identificam vias de formação | auxiliares para mitigação por controle de processo | matérias‑primas e condições de armazenamento | contribuindo para avaliação de risco e conformidade regulatória.
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