|
Characteristics |
White or almost white powder |
White powder |
|
Identification |
HPLC retention time of sample complies with that of known sample |
Conform |
|
Optical rotation |
「a」20D:+33.00 -+37.00 (c=10,CH3CN) |
36.50 |
|
Water |
NMT 1.0% |
0.2% |
|
Purity 1) Related substances
2) Residual solvents |
15R-Bimatoprost: NMT0.30% Bimatoprost free acid: NMT 0.10% 5,6-Trans-bimatoprost: NMT0.50% Any other single impurity: NMT:0.10% Total other impurities: NMT0.50%
Ter-Butylmethyl ether: NMT: 5000ppm Ethanol: NMT 5000ppm N-Hexane: NMT 290ppm Ethyl acetate NMT 5000ppm |
Not detected Not detected 0.01% 0.06% 0.09%
Not detected Not detected 6.82ppm Not detected |