Product name | Alogliptin benzoate |
CAS No. | 850649-62-6 |
Molecular Formula | C18H21N5O2.C7H6O2 |
Molecular Weight | 461.52 |
Quality Standard | 98% up by HPLC |
Appearance | White powder |
COA of Alogliptin Benzoate |
ITEMS | SPECIFICATION | RESULT |
Appearance | White or off-white crystalline powder | Complies |
Melting point | 181.0°C ~185.0°C | 182-184°C, melting and decomposition |
Specific rotation | +13° ~ +18° | +14.6° |
Identification | 1. UV: maximum absorption at the wavelength of 278+2nm | Complies |
2. IR: be consistent with standard | Complies |
3. HPLC： the retention time of the main peak of the solution should be consistent with the retention time of the main peak of the reference solution. | Complies |
Water | ≤ 0.5% | 0.15% |
Residue on ignition | ≤ 0.2% | 0.09% |
Heavy metals | ≤ 20 ppm | Complies |
Enantiomer | ≤ 0.5% | ND |
Residual solvents | Ethanol ≤ 5000ppm | 985 ppm |
DMF ≤ 880 ppm | ND |
DCM ≤ 600 ppm | ND |
TOL ≤ 890 ppm | ND |
IPA ≤ 5000 ppm | ND |
Related substances | Single impurity ≤ 0.1% | 0.01% |
Total impurities≤ 2.0% | 0.05% |
Assay | 98.0% - 102.0% | 100.01% |
Conclusion | The sample complies with the above specification |
Alogliptin benzoate is a selective inhibitor of dipeptidyl peptidase-4 (DPP-4). Eating stimulates the small intestine to secrete elevated concentrations of incretins, such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), into the bloodstream. These hormones cause islet beta cells to release insulin in a glucose-dependent manner, but these hormones are inactivated by the DPP-4 enzyme within minutes. Inhibition of DPP-4 activity by alogliptin slows the inactivation of these incretins, thereby increasing blood concentrations of these hormones and reducing fasting and postprandial blood glucose in a glucose-dependent manner in patients with type II diabetes.
