拉坦前列素Latanoprost

Description

Clear,Colourless or yellow, Viscous, oily liquid.

 light yellow liquid

Solubility

Practically insoluble in water, very soluble in

acetonitrile, freely soluble in anhydrous ethanol

Conform

Identification

A：IR

B：The retention time of the major peak in the chromatogram of the sample corresponds to that of the standard solution, as obtained in the assay.

Conform

Specific Rotation

+ 32° ~ + 37°

+ 35.7°

Water

≤0.5%

0.17%

Residue on ignition

≤ 0.5%

0.06%

Related substances(HPLC)

Related Compound E (15S-cis isomer) ≤ 0.4%

0.10%

Related Compound F (15R-trans isomer) ≤3.5%

Not detectable

Related Compound H (Latanoprost acid) ≤0.15%

0.01%

Other max single impurity≤ 0.1%

Not detectable

Sum of impurities other than F ≤1.0%

Not detectable

Residue Solvent

n-Hexane：≤ 0.029%

Not detectable

Ethanol： ≤ 0.5%

0.39%

Methanol：≤ 0.3%

Not detectable

Isopropanol ≤ 0.5%

Not detectable

Purity by HPLC

 94.0%~102.0%

99.8%