Linagliptin Impurity J, also designated 3-Aminopiperidine impurity, is a basic alicyclic diamine of formula C5H12N2 and molecular weight 100.16 g/mol, CAS 54012-73-6. The structure corresponds to a saturated piperidine-derived amine that may arise as a synthetic intermediate, coupling residue, or process-related contaminant during manufacture of heterocyclic pharmaceuticals. Owing to its low chromophore content and high polarity, trace determination commonly relies on LC-MS/MS, ion-pair LC, or GC-MS after derivatization, with capillary electrophoretic methods sometimes applicable. As a potentially amine-reactive process impurity, it is evaluated within impurity-control strategies aligned with ICH Q3A and, when relevant, ICH M7 principles.
References
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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