01. |
Appearance |
A yellow to yellowish-orange crystalline powder |
02. |
Identification |
A. Determine by UV |
B. Determine by TLC |
03. |
Solubility |
Practically insoluble in cold water and slightly soluble in boiling water.
Soluble in dilute acids and alkaline solution.
|
04. |
Assay % - by HPLC |
95.0% to 102.0% |
05. |
Water Content % |
5.0% to 8.5% |
06. |
Sulfated Ash |
≤ 0.3% |
07. |
Specific Optical Rotation |
+18° to +22° |
08. |
Related Substances |
Impurity A : NMT 0.5% |
Impurity D : NMT 0.6% |
Any Other Impurity : NMT 0.5% |
Total Impurity : NMT 1.0% |