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Heparin Sodium: GMP, COA, DMF available
Heparin Sodium: GMP, COA, DMF available
Supplier Info
[China Supplier]
Contact Person : Mr. Shen Jinhang
Tel : 86-519-81667066
Fax : 86-519-86567888
Product Detail
We support 1. Speicfication: EP 7.0, USP 34 2. Grades:Injectable grade, Tropical grade, Crude

Definition

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 porcineintestine 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.  

Usage

Heparin Sodium is indicated for venous thrombosis and its extension, acute myocardial infarction disease, hemodialysis and so on.

Specification

Test

Acceptance criteria

Origin

Porcine intestinal mucosa

Appearance

White or almost white, hygroscopic powder

Solubility

Freely soluble in water

Identification

A:delays the clotting of sheep plasma

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

Appearance of solution

Clear and not more intensely colored than intensity 5 of reference solution

pH

5.5~8.0

Nitrogen

1.5%~2.5%

Sodium

9.5%~12.5%

Nucleotide impurities

260nm: not greater than 0.15

Protein

Not more than 0.5%

Related substances

Dermatan sulfate: Not more than 2.0%

Total impurities: Not more than 3.0%

Galactosamine

Not more than 1.0%

Heavy metals

Not more than 20 ppm

Loss on drying

Not more than 8.0%

Bacterial endotoxins

Less than 0.01 IU/heparin IU

Potency

At least 180 IU/mg

Heparin Sodium: GMP, COA, DMF available

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