Alogliptin Impurity 28 (CAS 865758-96-9) | também referida como Alogliptin 6-cloro Impurity | é uma impureza relacionada ao processo de síntese de alogliptina. Esta substância exige caracterização analítica rigorosa para controle de qualidade farmacêutico | incluindo identificação por cromatografia líquida de alta resolução HPLC | espectrometria de massas e RMN para confirmação estrutural. O perfil de impurezas deve ser avaliado quanto a retardo de retenção | espectro de massas e impurezas correlacionadas | e integrado às especificações de lote. Informação robusta sobre estabilidade e vias de formação é essencial para mitigação do risco e desenvolvimento de métodos analíticos validados.
Referências
Dineen, Laura, et al. “Alogliptin (Nesina) for Adults with Type-2 Diabetes.†Pharmacy and Therapeutics, vol. 39, no. 3, 1 Mar. 2014, pp. 186–202, www.ncbi.nlm.nih.gov/pmc/articles/PMC4005122/.
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