Nadroparin Calcium
CAS No.: 37270-89-6 (Low molecular weight heparin)
Short Description:
Source: extracted from pig intestinal mucosa, degraded by sodium nitrite, and obtained after calcium transfer.
Function and use: Nadroparin calcium is a low molecular weight heparin, which is depolymerized from unfractionated heparin with antithrombotic and anticoagulant effects; it has high anticoagulant factor Xa activity and low anticoagulant Factor IIa or antithrombin activity. In surgery, for the prevention of venous thromboembolic disease in situations of high or high risk of venous thrombosis; for the treatment of established deep vein thrombosis; in combination with aspirin for the acute treatment of unstable angina and non-Q-wave myocardial infarction ; Prevention of clot formation in extracorporeal circulation during hemodialysis.
Nadroparin Calcium-Pharmacopoeia Standard: EP
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- factor Xa activity/ anti-factor 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 |
The solution is not more opalescent than reference suspension II and not more intensely coloured than reference solution Y5 |
|
| 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) |
|
Indications
In surgery, it is used for the prevention of venous thromboembolic disease in cases of medium-high or high risk of venous thrombosis.
Treatment of deep vein thrombosis that has developed.
Combined with aspirin for the treatment of unstable angina pectoris and acute phase of non-Q-wave myocardial infarction.
Prevention of blood clot formation during cardiopulmonary bypass during hemodialysis.
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