Item | Specification |
Appearance | Colorless to pale yellow oil |
Identification | IR, HPLC |
Solubility | Very soluble in Acetonitrile, freely soluble in Ethyl acetate and in Ethanol, practically insoluble in water |
Optical rotation | +31°~+38° |
Water determination | ≤2.0% |
Residue on ignition | ≤0.50 % |
Organic impurities | Isopropyl diphenylphosphorylpentanoate ≤0.1% |
Latanoprost related compound A≤3.5% | |
Latanoprost related compound B ≤0.5% | |
Any unspecified impurity ≤0.1% | |
Total impurities ≤0.5% | |
Limit of Latanoprost related compound E | ≤0.2% |
Residue solvent | Ethanol ≤0.5% |
n-Hexane ≤0.029% | |
Assay | 94.0%~102.0% |