A Impureza J da linagliptina, também designada impureza de 3-aminopiperidina, é uma diamina alicíclica básica de fórmula C5H12N2, massa molecular 100.16 g/mol e CAS 54012-73-6. A estrutura corresponde a uma amina saturada derivada de piperidina, podendo surgir como intermediário de síntese, resíduo de acoplamento ou contaminante relacionado ao processo na fabricação de fármacos heterocíclicos. Devido à baixa cromoforicidade e alta polaridade, a determinação em traços normalmente requer LC-MS/MS, LC em par iônico ou GC-MS após derivatização, com eletroforese capilar em بعضos casos. Como impureza de processo potencialmente reativa, é avaliada segundo ICH Q3A e, quando aplicável, princípios de ICH M7.
Referências
Chavan, Kamlesh, et al. “CHEMISTRY & BIOLOGY INTERFACE an Overview of Recent Development towards the Synthesis of Linagliptin a DPP- 4 Inhibitor.â€Â Chemistry & Biology Interface, vol. 10, no. 5, 2020, cbijournal.com/paper-archive/september-october-2020-vol-5/Review-Paper-1-an-overview-of-recent-development-towards-the-synthesis-of-linagliptin-a-dpp-4-inhibitor.pdf.
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