Specification
| Nadroparin calcium |
| Source |
Intestinal mucosa of pigs |
| Quality standard |
EP
|
| characters |
Appearance |
white or almost white; hygroscopic powder |
| solubility |
freely soluble in water |
| identification |
The 13C NMR spectrum obtained is similar to that obtained with the appropriate specific nadroparin calcium CRS |
| Anti- Xa activity/ anti- IIa: 2.5-4.0 |
| Mw: 3600 -5000Da, M≤2000: NMT 15%, M2000-8000: 75%-95%, M2000-4000: 35%-55% |
| It complies with the test for calcium |
| Appearance of solution |
NMT Intensity 5. |
| Ethanol |
≤1.0% |
| pH |
5.5-8.0 |
| N-NO groups |
≤ 0.25 ppm |
| Free sulfates |
≤ 0.5% |
| Molar ratio of Sulfate carboxylate |
≥1.8 |
| Nitrogen |
1.5 %-2.5 % (on the dried basis) |
| calcium |
9.5% -11.5% (on the dried basis) |
| Loss on drying |
NMT 10.0% |
| Bacterial endotoxins |
＜0.01EU/IU |
| Assay |
95-130 IU/mg (on the dried basis) |
Product Description
Nadroparin calcium is a new antithrombotic drug, which is obtained by depolymerizing heparin extracted from pig intestinal mucosa, with an average molecular weight of 4500 daltons. In vitro experiments showed that compared with heparin, low molecular weight heparin calcium had obvious anti Xa activity, but only slight anticoagulant activity. The risk of bleeding is far lower than heparin, and it has little effect on platelets. Subcutaneous injection has high bioavailability, long half-life and outstanding antithrombotic effect. Nadroparin calcium is a low molecular weight heparin preparation, which can make the ratio of anticoagulant factor Xa to IIa activity greater than 4, thus playing a strong anti thrombosis function and certain thrombolytic effect.