Alogliptin Impurity 3 (CAS 1108732-05-3) | identificado também como (S)-Alogliptin | é uma impureza quiral relevante observada durante a síntese e degradação do princípio ativo Alogliptin. Caracteriza-se por propriedades físico-químicas próximas ao API | exigindo técnicas analíticas sensíveis como HPLC com detecção UV | LC-MS e RMN para quantificação e elucidação estrutural. Sua presença pode afetar pureza | perfil de segurança e estabilidade do lote | impondo limites de especificação e investigação da via de formação. Estratégias de controle incluem otimização de etapas de purificação | controles em processo e estudos de degradação forçada para minimizar ocorrências e suportar justificativas regulatórias.
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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