Benefiting from the rapid growth of China's economy and the reform of the medical system, API manufacturers in China have rapidly improved their process technology, production quality, and registration and certification capabilities in the drug administration market, and their production scale continues to increase.
China's API products can be generally divided into three categories of bulk APIs, Featured APIs and patented APIs: (1) Bulk APIs include anti-infectives, vitamins, hormones and other large tonnages that do not involve patent issues Traditional chemical API. (2) Featured APIs include specialty chemical APIs represented by antihypertensive, antitumor, central nervous and hypoglycemic, which are mainly used to produce generic drugs whose patents are due or are about to expire, and have broad development prospects. (3) Patented pharmaceutical raw materials refer to the pharmaceutical active ingredients used in the manufacture of original drugs (patented drugs or innovative drugs), which mainly meet the clinical research, registration approval and commercialization of innovative drugs of international original drug companies and emerging biopharmaceutical companies. Demand at various stages of chemical sales, which also includes advanced intermediates that are used to produce the API but need to be supervised by regulatory authorities.
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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
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.
Tags :
Alogliptin benzoate
Alogliptin
Alogliptin benzoate powder
Alogliptin benzoate manufacturer
Alogliptin API
Alogliptin manufacturer
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