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Specifications

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