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Dalteparin sodium

  • Introduction
  • Specification

 

As a new antithrombotic drug, dalteparin sodium is the sodium salt of low molecular weight heparin obtained by nitrous acid depolymerization of heparin from pork intestinal mucosa. The average molecular weight of dalteparin sodium is about 6000 Da. The acute toxicity of dalteparin sodium is far less than heparin.

Dalteparin sodium is indicated for acute deep vein thrombosis, hemodialysis 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, hygroscopic powder

Identification

A:13C-NMR

B:the mass-average relative molecular mass ranges between 5600 and 6400, with a characteristic value of about 6000.

Lower than 3000: not more than 13.0%

Higher than 8000: 15.0%~25.0%

Anti-factor

Ⅹa activity

 110 IU/mg~210 IU/mg

 Anti-factor Ⅱa activity

 35 IU/mg~100 IU/mg

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

 1.9~3.2 

Appearance of solution

Clear and not more intensely colored than intensity 5 of reference solution

pH 

 5.5~8.0 

Nitrite 

Not more than 5 ppm 

Boron

Not more than 1 ppm

Nitrogen 

1.5%~2.5% 

Sodium

9.5%~12.5%

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 20 ppm

Loss on drying

Not more than 5.0%

Bacterial endotoxins  

Less than 0.01 IU/AⅩaIU 

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