A impureza dimer do Alogliptina benzoato | identificada como CAS 1268836-55-0 e formalmente descrita como 2-[[6-[[(3R)-1-[3-[(2-Cyanophenyl)methyl]-1-methyl-2 | 6-dioxopyrimidin-4-yl]piperidin-3-yl]amino]-3-methyl-2 | 4-dioxopyrimidin-1-yl]methyl]benzonitrile | é um subproduto de reação que pode ocorrer por acoplamento durante a síntese ou por degradação em formulações. Sua presença impacta a pureza e segurança do material ativo | exigindo monitoramento por métodos validados como UPLC-MS/MS e HPLC com detector PDA | com avaliação por espectrometria de massas e RMN para confirmação estrutural. Estratégias de controle incluem otimização de etapa sintética | condições de armazenamento e limites estabelecidos conforme orientações ICH para impurezas. Padrões de referência e validação analítica são essenciais para gestão de risco.
Referências
Zhang, Kun, et al. “A Developed HPLC Method for the Determination of Alogliptin Benzoate and Its Potential Impurities in Bulk Drug and Tablets.â€Â Asian Journal of Pharmaceutical Sciences, vol. 10, no. 2, Apr. 2015, pp. 152–58, https://doi.org/10.1016/j.ajps.2015.01.001.
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