Linagliptin 668270-12-0

99% up by HPLC/GMP application/PMDA/DMF

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Product Details

Product Information

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
Identity	(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.