曲伏前列素

Characteristic

Colorless or pale yellow oil

Conforms

Identification

By TLC:The Travoprost should be appear as Black Spots.

Conforms

By HPLC:The Retention time of the maior peak in the

chromatogram of the test preparation corresponding to that in the chromatogram of the standard preparation,

as per Assay test.

Conforms

Specific rotation

[a]_D^20:+52°~+58°(20mg/ml,Etoh,365nm)

+54.2°

Water

≤ 1.0%

0.5%

       RelatedSubstances

Travoprost Related compound A≤ 0.2%

Not detected

Epoxide derivative≤ 0.4%

0.02%

15-epi Diastereomer ≤ 0.1%

0.05%

5,6-Trans Isomer ≤ 3.5%

0.8%

15-Keto derivative ≤ 0.3%

Not detected

Any other impurity ≤ 0.1%

0.05%

Total impurities ≤ 4.0%

0.92%

    Residual sovents

Isopropanol ≤ 0.5%

0.20%

Ethyl acetate ≤ 0.5%

0.1%

n-Hexane ≤ 0.029%

Not detected

Ethanol ≤ 0.5%

0.35%

Assay

96%~102%(anhydrous and solvent free basis)

99.2%