Alogliptin Impurity 25 | identificada pelo CAS 1246610-72-9 | é uma impureza relacionada ao processo de síntese do Alogliptin que exige caracterização analítica detalhada e controle de qualidade rigoroso. Seu perfil físico-químico deve ser estabelecido por técnicas como HPLC | LC-MS e RMN para identificação | quantificação e elucidação estrutural. A presença desta impureza pode comprometer a pureza do ingrediente farmacêutico ativo e requer limites de especificação alinhados às diretrizes ICH Q3A e Q3B. Estudos de estabilidade | investigação de origem e desenvolvimento de métodos validados são essenciais para monitoramento contínuo durante desenvolvimento e produção.
Referências
Cada, Dennis J., et al. “Alogliptin.†Hospital Pharmacy, vol. 48, no. 7, 2013, pp. 580–592, www.ncbi.nlm.nih.gov/pmc/articles/PMC3839527/, 10.1310/hpj4807-580. Accessed 4 Nov. 2021.
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