Ardeparin sodium

Appearance： White or almost white,hygroscopic powder. Identification： A:Delay of clotting of recalcified citrated sheep plasma. …

 Appearance： White or almost white,hygroscopic powder. 

Identification：

A:Delay of clotting of recalcified citrated sheep plasma.

B:H-NMR Spectrum:conforms with EP specification of

heparin about H-NMR requirements.

C: The principal peak in the chromatogram obtained

with test solution is similar in retention time and shape to

the principal peak in the chromatogram obtained with

reference solution.

D:Positive sodium reaction.

Appearance of solution：

A: 5% w/v solution is clear and colourless.

B: Solution is not more intensely coloured than reference

solution BY5 or better.

PH ：5.5~ 8.0 

Nucleotide impurities：

0.4% aqueous solution w/v

260nm:max 0.15

260nm: 0.05

Protein ：≤ 0.5%(dried substance) 

Related substance：

Sum of dermatan sulfate and chondroitin sulfate:≤ 2.0%

Any other impurity: Free

Nitrogen： 1.5%~2.5%(dried substance) 

Sodium： 9.5%~12.5%(dried substance) 

Heavy metals： ≤ 30ppm 

Loss on drying ：≤8.0% 

Bacterial endotoxins： ≤ 0.01 IU/IU of heparin 

Microbial contamination：

A: Bacteria:≤ 10CFU/g

B:Mold and yeast: ≤ 10CFU/g

C: Specified micro organisms

Escherichia coli