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Enoxaparin sodium

  • Introduction
  • Specification

 

  Enoxaparin sodium is the sodium salt of low molecular weight heparin obtained by alkaline depolymerization of the benzyl ester derivative of heparin from pork intestinal mucosa. The potency is between 90 IU and 120 IU of anti-factor Xa activity per milligram, calculated with reference to the dried substance. The ratio of anti-factor Xa activity to anti-factorⅡa activity is between 3.3 and 5.3.
 
Enoxaparin sodium is indicated for venous thrombosis, deep venous thrombosis, unstable angina and Non-Q-Wave myocardial infarction, and hemodialysis 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 3800 and 5000, with a characteristic value of about 4500.

<2000: 12.0%~20.0%

2000~8000: 68.0%~82.0%

Anti-factor Ⅹa activity

90 IU/mg~125 IU/mg

Anti-factor Ⅱa activity

20.0 IU/mg~35.0 IU/mg

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

3.3~5.3

Appearance of solution

Clear and not more intensely colored than intensity 6 of reference solution

pH

6.2~7.7

Specific absorbance

231nm: 14.0~20.0

Benzyl alcohol

Not more than 0.1%(m/m)

Sodium

11.3%~13.5%

Nitrogen

1.5%~2.5%

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 10.0%

Bacterial endotoxins

Less than 0.01 IU/AⅩaIU

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