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Definition
Dalteparin sodium is the sodium salt of low molecular weight heparin obtained by nitrous acid depolymerization of heparin from pork intestinal mucosa.
Usage
As a new antithrombotic class, it is indicated for thromboprophylaxis in conjuntion with surgery, treatment of acute deep venous thrombosis, prevention of clotting during hemodialysis and hemofiltration and so on.
Specifications
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 |
Dalteparin Sodium: GMP, COA, DMF available