Appearance

Colorless or light yellow oil

Complies

Identification

IR of the sample should match with standard

Complies

RT of sample should match with standard in the

Related substances

Complies

Optical rotation

+31°~ +38°

+36°

Water content

≤2.0%

0.05%

Residue on ignition

≤0.5%

0.06%

Isopropyl diphenyl-

phosphorylpentanoate

≤0.1%

0.02%

Related Compound B

(15S-cis isomer)

≤0.5%

0.15%

Related Compound A

(5,6-trans isomer)

≤3.5%

0.21%

Related Compound E

(Latanoprost acid)

≤0.2%

N.D

Other max single impurity

≤0.1%

N.D

Total impurities

≤0.5%

N.D

Residue solvents

Acetone≤0.5%

N.D

Methanol≤0.3%

N.D

Toluene≤0.089%

N.D

Tetrahydrofuran≤0.072%

N.D

Ethyl acetate≤0.5%

0.09%

Dichloromethane≤0.06%

N.D

Assay

94%~102%

99.52%

Conclusion:

Complies with USP Standard