- Contact Person : Mr. Shen Jinhang
- Company Name : Changzhou Taikang Pharmaceutical Co., Ltd.
- Tel : 86-519-81667066
- Fax : 86-519-86567888
- Address : Jiangsu,Changzhou,Guoxiang Road 18, Wujing Economic Zone, Changzhou, Jiangsu
- Country/Region : China
- Zip : 213149
Heparin Sodium: GMP, COA, DMF available
Definition
Heparin, a sulphated glucosaminoglycan, is widely distributed in mammalian liver, lungs, heart, kidney, the thymus, spleen, intestinal mucosa, muscle and blood. So it can be extracted from porcineintestine or bovine lung or porcine lung. Heparin sodium produced by our company is extracted from porcine intestine. It has the characteristic property of delaying the clotting of freshly shed blood.
Usage
Heparin Sodium is indicated for venous thrombosis and its extension, acute myocardial infarction disease, hemodialysis and so on.
Specification
Test | Acceptance criteria |
Origin | Porcine intestinal mucosa |
Appearance | White or almost white, hygroscopic powder |
Solubility | Freely soluble in water |
Identification | A:delays the clotting of sheep plasma B:1H-NMR: complies with EP 7.0 specification of heparin sodium about 1H-NMR requirements C:Chromatographic identity: the retention time and the shape of the principal peak from the sample solution are similar to that from the standard solution D:complies with the test for sodium |
Appearance of solution | Clear and not more intensely colored than intensity 5 of reference solution |
pH | 5.5~8.0 |
Nitrogen | 1.5%~2.5% |
Sodium | 9.5%~12.5% |
Nucleotide impurities | 260nm: not greater than 0.15 |
Protein | Not more than 0.5% |
Related substances | Dermatan sulfate: Not more than 2.0% Total impurities: Not more than 3.0% |
Galactosamine | Not more than 1.0% |
Heavy metals | Not more than 20 ppm |
Loss on drying | Not more than 8.0% |
Bacterial endotoxins | Less than 0.01 IU/heparin IU |
Potency | At least 180 IU/mg |
Heparin Sodium: GMP, COA, DMF available