Vildagliptin

Vildagliptin is a once-daily dipeptidyl peptidase 4 (DPP-4) inhibitor used in the management of type 2 diabetes mellitus.

General Properties and Specifications of Vildagliptin:
Appearance: A white to off-white powder.
Assay on dried basis: 98% to 102%
Identifications: IR and HPLC to match with the standard.
Appearance of solution: Clear and as per standard.
Loss on drying @ 105C: 0.5% maximum.
Sulfated Ash: 0.1% maximum.
Heavy metals: 10 ppm maximum.
Enantiomeric purity: 0.5% maximum.
Impurity A (Cyclic Amidine): 0.1% maximum.
Impurity B (Amide): 0.3% maximum.
Impurity C (Diketopiperazine): 0.1% maximum.
Impurity D (Dialkylatedbyprodict): 0.1% maximum.
Total impurities: 0.5% maximum.
Diazabicycloundence impurity: 0.1% maximum.
Methanol: 3000 ppm maximum.
Ethanol: 5000 ppm maximum.
Isopropyl alcohol: 5000 ppm maximum.
Acetonitrile: 410 ppm maximum.
Dichloromethane: 600 ppm maximum.
Ethyl acetate: 5000 ppm maximum.
Dimethylformamide: 880 ppm maximum.
Acetone: 5000 ppm maximum.
Relative Density: about 1.27
Melting Point: 148C to 151C.
Boiling Point: 531C.
Flash Point: 275C.
Storage: Room temperature. Preferably refrigerate. Keep away from moisture and strong light/heat.