Alogliptin Impurity 15 (CAS 1108731-49-2) é uma impureza relacionada ao processo observada durante a síntese e armazenamento de alogliptina. Com perfil físico-químico definido por maior polaridade relativa e solubilidade moderada em solventes orgânicos | esta impureza exige identificação estrutural por LC-MS e confirmação por RMN. Detectável por HPLC com detecção UV e espectrometria de massa | sua presença influencia parâmetros de pureza e estabilidade do lote. A caracterização completa inclui determinação de massa exata | fragmentação e comportamento cromatográfico para definir métodos analíticos robustos e limites aceitáveis conforme diretrizes regulatórias e práticas de controle de qualidade farmacêutico.
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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