Language
Grade: Pharmaceutical Grade
Factory Location: Xiamen, China
Main Sales Markets: North America
Sample Provided: no
Payment Terms: L/C
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 |
COA of Linagliptin |
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 ppmIsopropanol ≤ 5000 ppmDMF ≤ 880 ppmDichloromethane ≤ 600 ppm |
ND4621 ppmNDND |
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 |
