Items | Specifications | Results |
Appearance | White to almost white powder | White powder |
Identification | HPLC retention time of sample complies with that of known sample | Complies |
Specific rotation | [a]D20: +33.0°~+37.0°(C=1.0,CH3CN) | +36.0° |
Water | ≤1.0% | 0.31% |
Related substances |
15R-Bimatoprost: ≤0.30% Bimatoprostfree acid: ≤0.10% 5,6-trans-Bimatoprost: ≤0.50% Any other single impurity: ≤0.10% Total other impurities: ≤ 0.50% |
Not detected Not detected 0.07% 0.05% 0.18% |
Residual solvents |
Ter-Butylmethyl ether: ≤ 5000ppm Ethanol: ≤5000ppm N-Hexane: ≤ 290ppm Ethyl acetate: ≤5000ppm |
Not detected Not detected 16.13ppm 18.92ppm |
Purity | ≥99.5% | 99.82% |