Hugestone Enterprise Co.,Ltd

Test

Acceptance criteria

Origin

Porcine intestinal mucosa

Appearance

White or almost white, hygroscopic powder

Solubility

Freely soluble in water

Identification

A:delays the clotting of sheep plasma
B:1H-NMR: complies with EP 7.0 specification of heparin sodium about 1H-NMR requirements
C:Chromatographic identity: the retention time and the shape of the principal peak from the sample solution are similar to that from the standard solution
D:complies with the test for sodium

Appearance of solution

Clear and not more intensely colored than intensity 5 of reference solution

pH

5.5~8.0

Nitrogen

1.5%~2.5%

Sodium

9.5%~12.5%

Nucleotide impurities

260nm: not greater than 0.15

Protein

Not more than 0.5%

Related substances

Dermatan sulfate: Not more than 2.0%
Total impurities: Not more than 3.0%

Galactosamine

Not more than 1.0%

Heavy metals

Not more than 20 ppm

Loss on drying

Not more than 8.0%

Bacterial endotoxins

Less than 0.01 IU/heparin IU

Potency

At least 180 IU/mg