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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
Usage
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.
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Pharma Sources Insight June 2024: Globalization on the Go
