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98% up by HPLC Linagliptin 668270-12-0
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更新 2025-08-14 05:39
 
详细信息

Grade: Pharmaceutical Grade

Factory Location: Xiamen, China

Main Sales Markets: North America

Sample Provided: no

Payment Terms: L/C

Product name

Linagliptin

CAS No.

668270-12-0

Molecular Formula

C25H28N8O2

Molecular Weight

472.55

Quality Standard

98% up by HPLC

Appearance

Off-white to light-yellow crystalline powder

 

COA of Linagliptin

 

ITEMS

SPECIFICATION

RESULT

Appearance

Off-white to light-yellow crystalline powder

Light yellow crystalline powder

Solubility

Soluble in methanol and sparingly soluble in 2-propanol

Conforms

 

 

Identity

(1) The infrared absorption spectrum of the sample in potassium bromide dispersion is concordant with that of a similar preparation of working standard.

 

Conforms

(2) The retention time of the main peak of testing solution should be confirmed with the reference solution in HPLC chromatogram.

 

Conforms

Melting point

200.0 。C - 206.0。C

203.0。C - 204.5。C

Loss on drying

≤ 1.0%

0.38%

Residual solvents

Methanol ≤ 3000 ppm

Isopropanol ≤ 5000 ppm

DMF ≤ 880 ppm

Dichloromethane ≤ 600 ppm

ND

4621 ppm

ND

ND

Residual on ignition

≤ 0.1%

0.08%

Related substance

Max single impurity ≤ 0.1%

Total impurities ≤ 1.0%

0.07%

0.21%

Heavy metals

≤ 10 ppm

Conforms

Isomer

≤ 0.15%

ND

Assay

98.0% - 102.0%

99.89%

Conclusion

The sample complies with the above specification

 

Usage

 

Linagliptin is an inhibitor of dipeptidyl peptidase 4 (DPP-4), which degrades incretin-like polypeptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Linagliptin increases the concentration of active incretin hormones, stimulates insulin release in a glucose-dependent manner, and reduces circulating glucagon levels.

 

Linagliptin in combination with metformin and sulfonylureas, with diet and exercise, can be used for glycemic control in adults with type II diabetes.