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Introduction
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Specification
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Nadroparin calcium is a new kind of antithrombotic drug. It is obtained by depolymerization of heparin. The average molecular weight of nadroparin sodium is about 4300 Da. Nadroparin calcium has obvious anti-factor Xa activity and affects the clotting time to a less degree than heparin.
Nadroparin calcium is mainly indicated for deep vein thrombosis, pulmonary embolism, hemodialysis, and unstable coronary artery disease (unstable angina and Non-Q-Wave myocardial infarction) and so on.
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. <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 |
|
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 |