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Introduction
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Specification
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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.
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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% |
| Ⅹa activity |
110 IU/mg~210 IU/mg |
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Anti-factor Ⅱa activity |
35 IU/mg~100 IU/mg |
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The ratio of Anti-factor Ⅹa / Anti-factor Ⅱa |
1.9~3.2 |
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Appearance of solution |
Clear and not more intensely colored than intensity 5 of reference solution |
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pH |
5.5~8.0 |
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Nitrite |
Not more than 5 ppm |
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Boron |
Not more than 1 ppm |
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Nitrogen |
1.5%~2.5% |
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Sodium |
9.5%~12.5% |
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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 5.0% |
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Bacterial endotoxins |
Less than 0.01 IU/AⅩaIU |