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Linagliptin 668270-12-0 Linagliptin 668270-12-0
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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.
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