Details:
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