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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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