1. Characters: White or almost white powder, highly hygroscopic.
2. Source: Porcine intestine mucosa.
3. Process: Heparin sodium is extracted from healthy porcine intestine mucosa.
4. Indications and uses: This product is mainly used for thromboembolic disease prevention, especially suitable for the need of anticoagulant quickly, such as: 1. Acute or chronic venous thrombosis or no significant blood flow dynamic change of pulmonary embolism(PE).Heparin can stop embolus extension to make time for spontaneous thrombolysis of body. 2. Prevention and treatment of Atrial fibrillation with embolism. 3. Treatment of early diffuse intravascular coagulation(DIC). 4. Prevention and treatment of peripheral arterial thrombosis or myocardial infarction. 5. Other in vitro anticoagulation: such as cardiovascular surgery, in vitro circulation, hemodialysis, angiography, also can be used for transfusion or blood specimen preparation, at present the main indications of heparin application are deep vein thrombosis(DVT), PE and thrombosis in high risk patients.
·Passed the Chinese GMP
·27 years of biological enzyme R&D history
·Raw materials are traceable
·Comply with USP、EP and customer standard
·Export to over 30 countries and regions
·Has the ability of quality system management such as US FDA, Japan PMDA, South Korea MFDS, etc.
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Test Items |
Company Specification |
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EP |
USP |
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Characters |
White or almost white powder, highly hygroscopic |
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Identification |
Thrombotest: Conforms |
Chromatographic identity: Conforms |
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1H NMR Spectrum: Conforms |
1H NMR Spectrum: Conforms |
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Liquid Chromatography: Conforms |
Weight-average molecular weight: 15000~19000 |
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Sodium: Conforms |
Sodium: Conforms |
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Anti-factor Xa to anti-factor IIa ratio:0.9~1.1 |
Anti-factor Xa to anti-factor IIa ratio:0.9~1.1 |
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Tests |
Clarity and color |
Clarity: Clear, Color: by 5 or better |
———— |
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Nitrogen |
1.5～2.5%（dry substance） |
1.3～2.5%（dry substance） |
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Nucleotidic impurities |
A260 ≤ 0.15(4mg/ml) |
≤ 0.1（w/w） |
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Related substances |
Conforms |
———— |
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Limit ofgalactosamine in total hexosamine |
———— |
≤ 1.0% |
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Oversulfated chondroitin sulfate |
———— |
Conforms |
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pH |
5.5～8.0（1%） |
5.5～7.5（1%） |
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Loss on drying |
≤ 8.0%（60℃ Dry in Vacuum, 3h） |
≤ 5.0%（60℃ Dry in Vacuum, 3h） |
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Residue on ignition |
———— |
28.0%～41.0% |
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Bacterial endotoxin |
≤ 0.01 IU/International Unit of Heparin |
≤ 0.03 USP U/International Unit of Heparin |
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Heavy metal |
≤ 30ppm |
≤ 30ppm |
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Sodium |
10.5～13.5%（dry substance） |
———— |
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Proteins |
≤ 0.5%（dry substance） |
≤ 0.1%（Weight ratio） |
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Activity |
≥ 180 IU/mg（dry substance） |
≥ 180 USP U/mg（dry substance） |
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Microbial Impurities |
TAMC |
≤ 1000cfu/g |
≤ 1000cfu/g |
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TYMC |
≤ 100cfu/g |
≤ 100cfu/g |
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E.coli |
Conforms |
Conforms |
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Staphylococcus aureus |
Conforms |
Conforms |
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Salmonella |
Conforms |
Conforms |
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