Item | Specification |
Appearance | White to off-white amorphous powder |
Identification | IR |
Sodium salt | |
Water determination | ≤3.0% |
15-Epimer | ≤1.0% |
5,6-Trans isomer | ≤1.0% |
Other maximum single impurity | ≤0.3% |
Total impurities | ≤1.5% |
Residual solvents | Ethanol ≤0.5% |
Methanol ≤0.3% | |
n-Hexane ≤0.029% | |
Toluene ≤0.089% | |
Tert-Butyl methyl ether ≤0.5% | |
Acetone ≤0.3% | |
Assay | 97.5%~102.5%, calculated on the anhydrous basis |