| TEST ITEMS |
SPECIFICATION |
RESULTS |
| Description |
White or Almost White Crystalline Powder |
| Solubility |
Practically insoluble in water, freely soluble in acetone and in alcohol, soluble in fatty oils. |
| Identification |
IR |
Positive |
| Assay(on dry bsis) |
97.0~103.0% |
98.85% |
| Specific Rotation |
+84°~+90° |
+85.9° |
| Loss On Drying |
0.5%max |
0.31% |
| Related Substances |
Any impurity: 0.5%max |
<0.5% |
| Total: 1.0%max |
<1.0% |
| Disregard limit: 0.05%max |
<0.05% |
| Conclusion |
The specifications conform with BP2010 standard. |
6 . HPLC
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