Test Items |
Specification |
Test Results |
|
Description |
White or off-white crystalline powder |
Off-white crystalline powder |
|
Specific rotation | -56°~-60° | -58.2° | |
Identification |
IR |
Matches with working standard |
Complies |
HPLC | |||
Solubility |
Freely soluble in chloroform and in alcohol; Very slightly soluble in water |
Conform | |
Heavy metals |
≤10ppm |
<10ppm |
|
Water |
≤0.3% |
0.22% |
|
Residue on ignition |
≤0.1% |
0.05% |
|
Relative material |
Maximum impurities≤0.5% |
0.36% |
|
Total impurities≤1.0% |
0.52% |
||
Assay |
98.5~101.0% |
99.68% |
|
Conclusion |
The specification conform with Enterprise standard |