155206-00-1

Description

White powder

white powder

Water

< 0.5 %

0.10%

Solubility

Very soluble in ethanol,methanol,sparingly to slightly soluble in water

complies

Identification

By HPLC HNMR

complies

Residue on Ignition

≤0.1%

0.05%

Heavy metals

≤10PPM

complies

Optical rotation

+33.0°~+37.0°( C=1.0,CH3ON)

+35.0°

Related substances

15-epi Bimatoprost ≤ 0.15%

15-keto Bimatoprost ≤ 0.15%

5,6-trans Bimatoprost：≤ 0.30%

Any other single impurity ≤0.2%

Total  impurities ≤1.0%

0.012%

0.007%

  0.087%

  N.D

  0.11%

Residue Solvent

Ethyl acetate ≤ 0.5%

0.06%

N-hexanol ≤0.029%

N.D

Ethanol ≤0.5%

N.D

Ether ≤0.5%

N.D

Ter-butylmetyl ether≤0.5%

N.D

Purity

≥99.5%

99.89%

Assay

96~102%

99.5%