Alogliptin Impurity 29 (CAS 1246610-74-1) é uma impureza relacionada observada durante síntese e purificação de alogliptina. Caracteriza-se por perfil espectral definido e propriedades físico-químicas que demandam monitoramento rigoroso no controle de qualidade. A presença desta impureza pode afetar pureza e perfil de segurança do fármaco | exigindo métodos analíticos validados como LC-MS e HPLC para identificação | quantificação e limites aceitáveis. Estudos de estabilidade e vias de formação ajudam a implementar estratégias de redução | incluindo otimização de etapas de reação e etapas de purificação. Fornecemos documentação analítica completa para suporte regulatório e investigação de desvios no processo.
Referências
Scott, Lesley J. “Alogliptin.†Drugs, vol. 70, no. 15, Oct. 2010, pp. 2051–72, https://doi.org/10.2165/11205080-000000000-00000. ?Moritoh, Yusuke, et al. “The Dipeptidyl Peptidase-4 Inhibitor Alogliptin in Combination with Pioglitazone Improves Glycemic Control, Lipid Profiles, and Increases Pancreatic Insulin Content in Ob/Ob Mice.†European Journal of Pharmacology, vol. 602, no. 2-3, Jan. 2009, pp. 448–54, https://doi.org/10.1016/j.ejphar.2008.11.017.
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