|
Specifications |
|
|
|
|
|
|
|
Appearance |
White crystalline powder |
|
|
|
|
|
|
Solubility |
Clear Solution |
|
|
|
|
|
|
Assay ,% |
98.5 ~ 101.5 |
|
|
|
|
|
|
Identification |
Infrared Absorption |
|
|
|
|
|
|
|
|
|
|
Sulfate(SO4),%(as SO4) |
≤0.03 |
|
|
|
|
|
|
|
|
|
|
Loss on drying,% |
≤0.4 |
|
|
|
|
|
|
|
|
|
|
Residue on ignition ,% |
≤0.1 |
|
|
|
|
|
|
|
|
|
|
Iron(as Fe),% |
≤0.003 |
|
|
|
|
|
|
|
|
|
|
Heavy metals (as Pb),% |
≤0.0015 |
|
|
|
|
|
|
|
|
|
|
Chloride(as CI),% |
19.0-19.6 |
|
|
|
|
|
|
|
|
|
|
Specific optical rotation |
+20.4°— +21.4° |
|
|
|
|
|
|
Chromatographic purity,% |
Individual impurity ≤0.5 |
|
|
|
Total impurities ≤2.0 |
|
|
|
|
|
|
Organic volatile impurities |
Meet the requirements |
|
|
Related substance |
Meets with the requirements |
|
|
|
|
|
|
Shelf Life |
2 years |
