TEST

SPECIFICTIONS

Description

Colorless or light yellow oil

Identification

IR of the sample should match with standard

RT of sample should match with standard in the Related substances

Optical rotation

+31°~ +38°

Water content

≤2.0%

Residue on ignition

≤0.5%

Isopropyl diphenyl- phosphorylpentanoate

≤0.1%

Related Compound A (5,6-trans isomer)

≤3.5%

Related Compound B (15S-cis isomer)

≤0.5%

Related Compound E (Latanoprost acid)

≤0.2%

Other max single impurity

≤0.1%

Total unknown impurities

≤0.5%

  Residue solvents

Acetone≤0.5%

Methanol≤0.3%

Toluene≤0.089%

Tetrahydrofuran≤0.072%

Ethyl acetate≤0.5%

Dichloromethane≤0.06%

Assay

94.0%~102.0%

Conclusion:

Complies with USP40 standards.