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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
Usage
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.
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