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