ITEMS |
STANDARD |
RESULTS |
Characters |
A white powder, very soluble in water, very slightly soluble in alcohol |
COMPLIES WITH |
Identification |
Specific optical rotation |
+195°~+201° |
+197.07° |
Infrared absorption spectrogram |
Comparing with the spectrum |
COMPLIES WITH |
obtained from dextran CRS |
Appearance of solution |
Clear and colourless |
COMPLIES WITH |
Acidity or alkalinity |
Reaction with phenolphtalein, Na OH and HC1 |
COMPLIES WITH |
Nitrogenous |
≤110ppm |
<60ppm |
Residual solvents |
Ethanol: ≤0.5% |
0.03% |
Methanol: ≤0.05% |
Not detected |
Other residual solvent: ≤0.5% |
COMPLIES WITH |
Molecular-mass distribution |
MW:54 000- 66000 |
MW:60563 |
M10: ≤180 000 |
M10: 110760 |
M90:≥14 000 |
M90:15241 |
Heavy metals |
≤10ppm |
<5ppm |
Loss on drying |
≤7.0% |
4.22% |
Sulphated ash |
≤0.3% |
0.04% |
Bacterial endotoxins |
≤16IU/g |
5IU/g |
Microbial contamination |
Total viable aerobic≤100/g |
<10/g |
No colibacillus |
Not detected |