TEST ITEMS |
SPECIFICATION |
RESULTS |
Description |
White Crystalline Powder |
White Powder |
Identification |
Positive |
Positive |
Assay(by HPLC) |
98.0~102.0% |
98.64% |
Absorbance(E1cm) |
465~495 |
482.5 |
Melting Point |
191~195°C |
193.5~195.0°C |
Loss On Drying |
0.5%max |
0.19% |
Specific Rotation |
+288°~ +298° |
+290.2° |
Residue On Ignition |
0.1%max |
0.03% |
Related Substances |
Total:1.5%max |
<1.3% |
|
Single:0.5%max |
<0.4% |
Residue Solvents |
0.2%max |
0.10% |
Heavy Metals |
20PPm max |
<10PPm |
|
|
|
Conclusion |
The specification conform with enterprise standard. |