Synonyms 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: : Ardeparin sodium; Deligoparin sodium; Minolteparin sodium; Nadroparine sodium
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 +35 O
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: