Our Heparin Sodium product is manufactured according to the requirements of EP, BP, USP or customers’ specifications.
Item |
Specification |
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 |