Dalteparin Sodium complies with 1. Speicfication: EP 7.0 2. Injectable Grade
Definition
Nadroparin calcium is the calcium salt of low molecular weight heparin obtained by nitrous acid depolymerisation of heparin from pork intestinal mucosa.
Usage
As a new antithrombotic class, it is indicated for prophylaxis of thromboembolic disorders, treatment of deep vein thrombosis, prevention of clotting during hemodialysis, treatment of unstable angina and non-Q wave myocardial infarction 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 3600 and 5000, with a characteristic value of about 4300. Lower than 2000: not more than 15% 2000~8000: 75.0%~95.0% 2000~4000: 35.0%~55.0% |
Anti-factor Xa activity | 95 IU/mg~130 IU/mg |
The ratio of Anti-factor Xa / Anti-factor Ⅱa | 2.5~4.0 |
Appearance of solution | Not more opalescent than reference suspensionⅡand not more intensely colored than reference solution Y5 |
pH | 5.5~8.0 |
Ethanol | Not more than 0.5%(m/m) |
N-NO groups | Not more than 0.25 ppm |
Free sulfates | Not more than 0.5% |
Nitrogen | 1.5%~2.5% |
Calcium | 9.5%~11.5% |
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% |
Bacterial endotoxins | Less than 0.01 IU/AXaIU |
Nadroparin Calcium: GMP, COA, DMF available
