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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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