Impureza do dimer da alogliptina é um derivado de dimerização formado durante a síntese ou armazenamento | apresentando massa molecular dobrada e propriedades físico-químicas distintas do princípio ativo. A caracterização exige técnicas analíticas robustas como HPLC com detectores UV | LC-MS para determinação da massa | e RMN para confirmação estrutural. Esta impureza pode afetar a pureza e a potência do lote | exigindo perfilamento | limites especificados em acordo com ICH Q3A/Q3B e estratégias de controle via otimização de processo | purificação e estudos de estabilidade. Padrões de referência e métodos validados são essenciais para quantificação precisa e monitoramento contínuo.
Referências
“Cada, D. J., Levien, T. L., & Baker, D. E. (2013). Alogliptin. Hospital Pharmacy, 48(7), 580–592. https://doi.org/10.1310/hpj4807-580
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