pyrrolidine-2-carbonitrile Hydroxytricyclo 274901-16-5
Name: Vildagliptin
CAS No.: 274901-16-5
MF: C17H25N3O2
Use: Anti-diabetic agent
Appearance: White powder
General introduction: Vildagliptin (previously identified as LAF237, trade name ZOMELIS) is an oral anti-hyperglycemic agent (anti-diabetic drug) of the new dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs. Vildagliptin inhibits the inactivation of GLP-1 and GIPby DPP-4, allowing GLP-1 and GIP to potentiate the secretion of insulin in the beta cells and suppress glucagon release by the alpha cells of the islets of Langerhans in the pancreas.
Vildagliptin has been shown to reduce hyperglycemia in type 2 diabetes mellitus.
The Food and Drug Administration had demanded additional clinical data before it could approve vildagliptin including extra evidence that skin lesions and kidney impairment seen during an early study on animals have not occurred in human trials.
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Appearance |
White crystalline powder |
Conforms |
Identification |
IR/HPLC |
Conforms |
Melting point |
148.0-150.0°C |
148.5-149.2°C |
Loss on drying |
≤ 1.0% |
0.18% |
Residue on ignition |
≤ 0.1% |
0.05% |
Heavy metals |
≤20ppm |
Conforms |
Sulphate |
≤ 0.02% |
Conforms |
Chloride |
≤ 0.05% |
Conforms |
Ethyl acetate |
≤ 0.5% |
0.11% |
Related impurity |
Single impurity≤ 0.5% Total impurities≤ 1.0% |
0.15% Conforms |
Purity |
≥99.0% |
99.85% |
Appearance |
White crystalline powder |
Conforms |
Identification |
IR/HPLC |
Conforms |
Melting point |
148.0-150.0°C |
148.5-149.2°C |
Loss on drying |
≤ 1.0% |
0.18% |
Residue on ignition |
≤ 0.1% |
0.05% |
Heavy metals |
≤20ppm |
Conforms |
Sulphate |
≤ 0.02% |
Conforms |
Chloride |
≤ 0.05% |
Conforms |
Ethyl acetate |
≤ 0.5% |
0.11% |
Related impurity |
Single impurity≤ 0.5% Total impurities≤ 1.0% |
0.15% Conforms |
Purity |
≥99.0% |
99.85% |
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