China H&Z® Vildagliptin Factory
Vildagliptin CAS:274901-16-5
Vildagliptin Chemical Properties
MF:C17H25N3O2
MW:303.4
Melting point:153-155C
Boiling point:531.3±50.0°C(Predicted)
Density:1.27
Fp:275.1℃
Vildagliptin Specification:
Items |
Standards |
Analytical results |
Appearance |
White crystal powder |
White crystal powder |
Solubility
|
Easy to dissolve in methanol,ethanol,dimethyl sulfoxide,water or 0.01mol/L hydrochloric acid solution,slightly soluble in acetonitrile or isopropanol. |
Conform |
Identification |
Identical to the HPLC retention of standard. |
Conform |
Identical to the IR specyrum of standard. |
Conform |
|
Water |
≤1.0% |
0.21% |
Melting point |
148℃-152℃ |
149.3-151.4℃ |
Residue on ignition |
≤0.1% |
0.03% |
Heavy metals |
≤20ppm |
<20ppm |
Sulphate |
≤0.02% |
Conform |
Chloride |
Conform |
|
Chiral impurity |
R-isomer impurity≤0.5% |
0.01% |
Residual solvent |
Ethanol≤5000ppm |
318ppm |
Acetone≤5000ppm |
33ppm |
|
Acetonitrile≤410ppm |
ND |
|
Butyl acetate≤5000ppm |
ND |
|
DMF≤880ppm |
ND |
|
Ethyl acetate≤5000ppm |
ND |
|
Methanol≤3000ppm |
ND |
|
Methylene Chloride≤600ppm |
ND |
|
Methyl ethyl ketone≤5000ppm |
ND |
|
Toluene≤890ppm |
ND |
|
Isopropyl Alcohol≤5000ppm |
ND |
|
Related impurity (HPLC) |
Impurity B≤0.15% |
ND |
Impurity C≤0.2% |
0.08% |
|
Individual impurity≤0.1% |
0.04% |
|
Total impurities≤1.0% |
0.17% |
|
Related impurity (GC) |
Impurity A≤0.15% |
ND |
HPLC assay |
98.0%~102.0% |
99.6% |
Particle size |
D90≤150μ |
D90<100μ |
Conclusion |
Conforms withEnterprisestandard. |