Specification :

Heparin Sodium
Synonyms: Ardeparin sodium; Deligoparin sodium; Minolteparin sodium; Nadroparine sodium
CAS No.: 9041-08-01 Molecular weight: 8, 000-25, 000 dalton
Description:
Heparin Sodium is a sulphated glycosaminoglycans prepared from the intestinal mucosa of healthy pigs. It has the characteristic property of delaying the clotting of freshly shed blood through its action on antithrombin III which inhibits the activity of thrombin and Factor Xa. Thrombin and Factor Xa influence conversion of fibrinogen to fibrin, which is the main clotting process.
Specification:
Item index
Origin Intestinal mucosa of healthy pigs
Characters A white or almost white powder, moderately hygroscopic, freely soluble in water
Delays the clotting It delays the clotting of recalcified citrated sheep plasma
Specific optical rotation Not less than +35O
Zone electrophoresis The ratio of the mobility of the principal band or bands in the electropherogram obtained with the test solution to the mobility of the band in the electropherogram obtained with the reference solution is 0.9 to 1.1
Reaction of sodium Positive reaction of sodium
Appearance of solution The solution is clear and not more intensely coloured than intensity 5 of the range of reference solutions of the most appropriate colour.
pH Between 5.5 and 8.0
Protein and nucleotidic impurities OD 260nm not more than 0.200
OD 280nm not more than 0.150
Nitrogen Not more than 2.5%
Sodium Between 9.5% and 12.5%
Heavy metals Not more than 30 ppm
Loss on drying Not more than 8.0%
Sulphated ash Between 30% and 43%
Assay (on dry basis) Between 90% and 111% of the stated potency
Bacterial endotoxins Not more than 0.01 IU/IU
Microbial count Not more than 50 CFU/g
Yeasts and moulds Negative

Packaging and storage:
Heparin Sodium is sealed in a double-layer pharmaceutical polyethylene bag, put in a pharmaceutical aluminum tin in an outer carton. Package size is normally 1, 000 mega units/carton. Store in airtight containers.
Keywords:
Heparin Sodium; Ardeparin sodium; Deligoparin sodium; Minolteparin sodium; Nadroparine sodium