La Impureza J de linagliptina, también designada impureza de 3-aminopiperidina, es una diamina alicíclica básica con fórmula C5H12N2, masa molecular de 100.16 g/mol y CAS 54012-73-6. La estructura corresponde a una amina saturada derivada de piperidina que puede originarse como intermedio de síntesis, residuo de acoplamiento o contaminante relacionado con el proceso durante la fabricación de fármacos heterocíclicos. Por su escasa absorción cromofórica y elevada polaridad, la determinación de trazas suele requerir LC-MS/MS, LC con par iónico o GC-MS tras derivatización, y en algunos casos electroforesis capilar. Como impureza de proceso potencialmente reactiva, se valora conforme a ICH Q3A y, cuando procede, ICH M7.
Referencias
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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