Product name | Linagliptin |
CAS No. | 668270-12-0 |
Molecular Formula | C25H28N8O2 |
Molecular Weight | 472.55 |
Quality Standard | 98% up by HPLC |
Appearance | Off-white to light-yellow crystalline powder |
ITEMS | SPECIFICATION | RESULT |
Appearance | Off-white to light-yellow crystalline powder | Light yellow crystalline powder |
Solubility | Soluble in methanol and sparingly soluble in 2-propanol | Conforms |
Identity | (1) The infrared absorption spectrum of the sample in potassium bromide dispersion is concordant with that of a similar preparation of working standard. |
Conforms |
(2) The retention time of the main peak of testing solution should be confirmed with the reference solution in HPLC chromatogram. |
Conforms |
Melting point | 200.0 。C - 206.0。C | 203.0。C - 204.5。C |
Loss on drying | ≤ 1.0% | 0.38% |
Residual solvents | Methanol ≤ 3000 ppm Isopropanol ≤ 5000 ppm DMF ≤ 880 ppm Dichloromethane ≤ 600 ppm | ND 4621 ppm ND ND |
Residual on ignition | ≤ 0.1% | 0.08% |
Related substance | Max single impurity ≤ 0.1% Total impurities ≤ 1.0% | 0.07% 0.21% |
Heavy metals | ≤ 10 ppm | Conforms |
Isomer | ≤ 0.15% | ND |
Assay | 98.0% - 102.0% | 99.89% |
Conclusion | The sample complies with the above specification |
Linagliptin is an inhibitor of dipeptidyl peptidase 4 (DPP-4), which degrades incretin-like polypeptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Linagliptin increases the concentration of active incretin hormones, stimulates insulin release in a glucose-dependent manner, and reduces circulating glucagon levels.
Linagliptin in combination with metformin and sulfonylureas, with diet and exercise, can be used for glycemic control in adults with type II diabetes.
