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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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