Item | Specification |
Appearance | White or almost white powder |
Solubility | Freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. |
Identification | IR, HPLC |
Loss on drying | ≤0.5% |
Residue on ignition | ≤0.10% |
Enantiomeric and Dia-stereomeric purity By HPLC | 6R,12aS Dia-stereomer ≤0.1% |
6S,12aS Enantiomer ≤0.1% | |
6S,12aR Dia-stereomer ≤0.1% | |
Chromatographic Purity by HPLC | Individual impurity ≤0.1% |
Total impurities ≤0.3% | |
Assay by HPLC (on dried basis) | 97.5%~102.5% |