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Introduction
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Specification
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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.
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Test |
Acceptance criteria |
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Origin |
Porcine intestinal mucosa |
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Characters |
White or almost white, hygroscopic powder |
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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% |
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Anti-factor Ⅹa activity |
90 IU/mg~125 IU/mg |
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Anti-factor Ⅱa activity |
20.0 IU/mg~35.0 IU/mg |
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The ratio of Anti-factor Ⅹa / Anti-factor Ⅱa |
3.3~5.3 |
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Appearance of solution |
Clear and not more intensely colored than intensity 6 of reference solution |
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pH |
6.2~7.7 |
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Specific absorbance |
231nm: 14.0~20.0 |
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Benzyl alcohol |
Not more than 0.1%(m/m) |
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Sodium |
11.3%~13.5% |
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Nitrogen |
1.5%~2.5% |
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Nucleotide and protein impurities of the source material |
260nm: not greater than 0.20 280nm: not greater than 0.15 |
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Molar ratio of sulfate ions to carboxylate ions |
Not less than 1.8 |
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Heavy metals |
Not more than 20 ppm |
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Loss on drying |
Not more than 10.0% |
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Bacterial endotoxins |
Less than 0.01 IU/AⅩaIU |