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Synonyms: Ardeparin sodium; Deligoparin sodium; Minolteparin sodium; Nadroparine sodium
CAS No.: 9041-08-01 Molecular weight: 8, 000-25, 000 dalton
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.
|
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 |
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.
Heparin Sodium; Ardeparin sodium; Deligoparin sodium; Minolteparin sodium; Nadroparine sodium
