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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.
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Test |
Acceptance criteria |
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Origin |
Porcine intestinal mucosa |
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Characters |
White or almost white，hygroscopic powder |
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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% |
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Anti-factor Ⅹa activity |
95 IU/mg~130 IU/mg |
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The ratio of Anti-factor Ⅹa / Anti-factor Ⅱa |
2.5~4.0 |
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Appearance of solution |
Not more opalescent than reference suspensionⅡand not more intensely colored than reference solution Y5 |
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pH |
5.5~8.0 |
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Ethanol |
Not more than 0.5%(m/m) |
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N-NO groups |
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Free sulfates |
Not more than 0.5% |
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Nitrogen |
1.5%~2.5% |
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Calcium |
9.5%~11.5% |
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Nucleotide and protein impurities of the source material |
260nm: not greater than 0.20 280nm: not greater than 0.15 |
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Molar ratio of sulfate ions to carboxylate ions |
Not less than 1.8 |
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Heavy metals |
Not more than 20 ppm |
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Loss on drying |
Not more than 10% |
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Bacterial endotoxins |
Less than 0.01 IU/AⅩaIU |