TEST

SPECIFICTIONS

Description

A white or almost white, crystals or crystalline powder

Identification

According to the requirements

Optical rotation

-90.0°~-82.0°

Congealing temperature

68℃

Loss on drying

≤2.0%

Water content

≤0.5%

15-Oxo-dinoprostone

≤1.0%

15-Epi-dinoprostone

8-Isodinoprostone

Dinoprostone related compound C

≤2.0%

(5Z,13E,15S)-15-Hydroxy-9-oxoprosta-5, 10,13-triene-1-oic acid

≤1.0%

(5Z,13E,15S)-15-Hydroxy-9-oxoprosta-5, 8(12),13-trien-1-oic acid

≤1.0%

Any individual unspecified impurity

≤0.1%

  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