98% up by HPLC Alogliptin Benzoate 850649-62-6

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