• 中文
  • English

Welcome to the website of  CSBIO !

  • Home
  • News
  • About us
  • Culture
  • Products and R&D
    • API
    • Finished Products
    • Products under Registration
  • Human Resources
  • Contact us
Products and R&D
  • API
    • Heparin sodium
    • Low Molecular Weight Heparin Calcium
    • Dalteparin Sodium
    • Enoxaparin Sodium
    • Nadroparin Calcium
    • Levobupivacaine Hydrochloride
    • Slidenafil Citrate
  • Products under Registration
    • Dalteparin sodium injection
    • Enoxaparin sodium injection
    • Nadroparin calcium injection
    • Levobupivacaine hydrochloride injection

>
Home>>Products and R&D>>API

Heparin sodium

  • Introduction
  • Specification

 

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 porcine intestine 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.

Heparin Sodium Injection is indicated for venous thrombosis and its extension, acute myocardial infarction disease, hemodialysis and so on.

 

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

 

 

Changshan Biochemical Pharmaceutical(Jiangsu)Co.,Ltd          Supported by Wuxi KingWay Technology