|
Item |
Standard |
Results |
|
Appearance |
A white or almost white crystalline odorless powder |
Conforms |
|
Identification |
A green color is produced; Solution: Clear & colorless |
Conforms |
|
The retention time of the primcipal peak in the chromatogram obtained with the test solution is identical with that of the principal peak in the chromatogram obtained with the reference solution |
Conforms |
|
|
The infrared absorption spectrum is concordant with the standard spectrum |
Conforms |
|
|
The aqueous solution yields the reaction(l) characteristic of sodium salts |
Conforms |
|
|
Assay |
≥98.0% |
99.4% |
|
Chloride |
≤0.05% |
Conforms |
|
Ammonium salt |
≤0.05% |
Conforms |
|
Iron Salt |
≤0.01% |
Conforms |
|
Phosphate |
≤0.1% |
Conforms |
|
pH |
6.0-7.5 |
6.5 |
|
Loss on drying |
≤6.0% |
0.90% |
|
Heavy metals |
≤5 ppm |
Conforms |
|
Arsenic |
≤1 ppm |
Conforms |
|
Related substances |
5-CMP ≤0.3% |
0.012% |
|
Single impurity ≤0.2% |
0.021% |
|
|
Total of other impurity ≤0.7% |
0.06% |
|
|
Residual solvents |
Limit of methanol ≤0.3% |
N.D |
|
Limit of ethanol ≤0.5% |
N.D |
|
|
Limit of acetone ≤0.5% |
N.D |
|
|
Endotoxin |
No more than 0.3 EU/mg |
Conforms |
|
Total bacterial count |
≤800 CFU/g |
Conforms |
|
Yeast & mold |
≤80 CFU/g |
Conforms |
|
E.Coli |
Negative |
N.D |