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Introduction
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Specification
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Heparin, a sulphated glucosaminoglycan, is widely distributed in mammalian liver, lungs, heart, kidney, the thymus, spleen, intestinal mucosa, muscle and blood. So it can be extracted from
porcine
intestine or bovine
lung or porcine lung. Heparin sodium produced by our company is extracted from porcine
intestine. It has the characteristic property of delaying the clotting of freshly shed blood.
Heparin Sodium Injection is indicated for venous thrombosis and its extension, acute myocardial infarction disease, hemodialysis and so on.
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Test |
Acceptance criteria |
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Origin |
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Solubility
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Freely soluble in water |
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Identification
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B：1H-NMR:complies with EP 7.0 specification of heparin sodium about 1H-NMR requirements
C：Chromatographic identity: the retention time and the shape of the principal peak from the sample solution are similar to that from the standard solution
D：complies with the test for sodium
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Appearance of solution
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Clear and not more intensely colored than intensity 5 of reference solution
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pH
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5.5~8.0
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Nitrogen
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1.5%~2.5%
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Sodium
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9.5%~12.5%
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Nucleotide impurities
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Protein
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Not more than 0.5%
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Related substances
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Dermatan sulfate Not more than 2.0%
Total impurities Not more than 3.0%
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Galactosamine
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Not more than 1.0%
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Heavy metals
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Not more than 20 ppm
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Loss on drying
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Not more than 8.0%
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Less than 0.01 IU/heparin IU
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At least 180 IU/mg
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