TEST

SPECIFICTIONS

Description

A white or almost white, crystals or crystalline powder

Identification

According to the requirements

Optical rotation

-53.0°~-61.0°

Melting point

114~118℃

Residue on ignition

≤0.5%

Water content

≤0.5%

Prostaglandin A1

≤1.5%

Prostaglandin B1

≤0.1%

Any foreign prostaglandin impurity eluting before prostaglandin A1

≤0.9%

Impurity at relative retention time 0.6, relative to prostaglandin A1

≤0.9%

  Residue solvents

Acetone≤0.5%

Methanol≤0.3%

Toluene≤0.089%

Tetrahydrofuran≤0.072%

Ethyl acetate≤0.5%

Dichloromethane≤0.06%

Assay

95%~105%

Conclusion:

Complies with USP standards