Appearance

Colorless or light yellow oil

Complies

Identification

According to the requirements

Complies

Optical rotation（365nm）

+520°~+580°

545°

Water content

≤1.0%

0.1%

Travoprost related compound A

 ≤0.2%

0.02%

Epoxide derivative

≤0.4%

N.D

15-epi Diastereomer

≤0.1%

0.06%

5,6-trans Isomer

≤3.5%

0.31%

15-Keto derivative

≤0.3%

N.D

Any other individual impurity

≤0.1%

 0.03%

Total impurities

≤4.0%

 0.17%

Residue solven

Acetone≤0.5

N.D

Methanol≤0.3

N.D

Toluene≤0.089

N.D

Tetrahydrofuran≤0.072

N.D

Ethyl acetate≤0.5

0.05%

Dichloromethane≤0.06

N.D

Assay

96%~102%

99.2%

Conclusion:

Complies with USP Standard