Item | Specification |
Appearance | White or slightly yellowish crystalline powder |
Identification | IR |
Residue on ignition | ≤0.5% |
Limit of chromium | ≤0.002% |
Limit of rhodium | ≤0.002% |
Related substances | Prostaglandin A1 ≤1.5% |
Prostaglandin B1 ≤0.1% | |
Any foreign prostaglandin impurity eluting before prostaglandin A1 ≤0.9% | |
Impurity at relative retention time 0.6, relative to prostaglandin A1 ≤0.9% | |
Sum of the impurities at relative retention times 2.0 and 2.3 ≤0.6% | |
Any other foreign prostaglandin impurity eluting after prostaglandin A1 ≤0.9% | |
Total impurities ≤2.0% | |
Water determination | ≤0.5% |
Residual solvents | Ethanol ≤5000ppm |
Acetone ≤5000ppm | |
Dichloromethane ≤600ppm | |
N-Hexane ≤290ppm | |
N-Heptane ≤5000ppm | |
Ethyl acetate ≤5000ppm | |
Assay (on the anhydrous basis) | 95.0%~105.0% |