Products
Vildagliptin
| No. | Item | Specification |
| 1 | Appearance | White oralmost white crystalline powder |
| 2 | Identification | IR: corresponds to the standard UV: corresponds to the standard |
| 3 | Specific optical rotation(º) | 1.0% methanol(20ºC), +96 - +100 |
| 3 | Assay (%)(dry bass) | 99.0-101.0 |
| 4 | Water(%) | ≤0.5 |
| 5 | Sulphated ash(%) | ≤0.1 |
| 6 | Related substances(HPLC)(%) | impurity A ≤0.1 impurity B ≤0.1 impurity C ≤0.1 Max individual impurity ≤0.1 Total impurities ≤0.5 |
| 7 | Heavy Metals(as Pb)(ppm) | ≤20 |
| 8 | Residual solvent(%) | 2-butanone ≤0.5 |
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