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Low molecular weight heparin calcium

  • Introduction
  • Specification


  
Low molecular weight heparin calcium ( LMWH-Ca ) is a new kind of antithrombotic drug. It is obtained by depolymerization of heparin. The average molecular weight of LMWH-Ca is about 4500 Da. LMWH-Ca has obvious anti-factor Xa activity and affects the clotting time to a less degree than heparin.

  The LMWH-Ca injection is mainly indicated for deep vein thrombosis and pulmonary embolism, hemodialysis, and unstable coronary artery disease (unstable angina and Non-Q-Wave myocardial infarction) and so on.

 

Test

Acceptance criteria

Origin

Porcine intestinal mucosa

Characters

White or almost white powder, hygroscopic. Freely soluble in water

Identification

 

 A:13C-NMR

B:Anti-factor Ⅹ a / Anti-factor Ⅱa is not less than 1.5

C:the mass-average relative molecular mass is not greater than 8000 .

<8000: not less than 60.0%

D:complies with the test for calcium

Anti-factor Ⅹa activity 

 Not less than 70 IU/mg 

The ratio of Anti-factor Ⅹa / Anti-factorⅡa

Not less than 1.5

 pH

 5.5~8.0

Nitroge

1.5%~2.5%

Calcium

9.5%~11.5%

Nucleotide and protein impurities of the source material

260nm: not greater than 0.20

280nm: not greater than 0.15

Molar ratio of sulfate ions to carboxylate ions 

Not less than 1.8


Heavy metals

 Not more than 30 ppm

Nitrite

 Complie

Loss on drying

 Not more than 10.0%

Bacterial endotoxins

Less than 0.01 IU/AⅩaIU

 

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