Dalteparin sodium-low molecular weight heparin

Test

Acceptance criteria

Origin

Porcine intestinal mucosa

Characters

White or almost white, hygroscopic powder

Identification

A. ¹³C-NMR

B. the mass-average relative molecular mass ranges between 5600 and 6400, with a characteristic value of about 6000.

Lower than 3000: not more than 13.0%

Higher than 8000: 15.0%~25.0%

Anti-factor  Xa activity

110 IU/mg~210 IU/mg

Anti-factor Ⅱa activity

35 IU/mg~100 IU/mg

The ratio of Anti-factor Xa / Anti-factor Ⅱa

1.9~3.2

Appearance of solution

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

pH

5.5~8.0

Nitrite

Not more than 5 ppm

Boron

Not more than 1 ppm

Nitrogen

1.5%~2.5%

Sodium

9.5%~12.5%

Nucleotide and protein impurities of the source material

260nm: not greater than 0.20

280nm: not greater than 0.15

Molar ratio of sulfate ions to carboxylate ions

Not less than 1.8

Heavy metals

Not more than 20 ppm

Loss on drying

Not more than 5.0%

Bacterial endotoxins

Less than 0.01 IU/AXaIU