Tests | Standards |
Characteristics | A yellowish or orange, crystalline powder |
Identification | A:Specific optical rotation:+18 to +22 (anhydrous substance) |
B:HPLCchromatograms:Complies | |
C:TLC Identification:Complies | |
Related substance | Impurity Anot more than 0.5% |
Impurity D not more than 0.6% | |
any other impurity not more than0.5% | |
Total of other impurity not more than 1.0% | |
Water | 5.0--8.5% |
Residue on ignition | Not more than0.20% |
Assay(anhydrous basis) | 96.0~102.0% |