D-氯前列稀醇钠

Appearance

A white or almost white amorphous powder;

hygroscopic

White amorphous powder; hygroscopic

Solubility

Free soluble in water,in ethanol(95%)and in methanol;practically insoluble in acetone

Conforms

Identification

IR,HPLC

White precipitate is observed in characteristic

testing of sodium salts

Conforms

Water

≤3.0%

0. 12%

Specific Rotation

+ 25 。 ~ + 30 。(C= 1,in Ethanol)

+ 29.5

15-epimer

5,6-trans isomer

(-)-enantiomer

Other single impurity

Total impurities

≤1.0%

≤2.0%

≤2.0%

≤0.5% ≤2.5

N.D

0.1%

N.D

N.D

0.1%

Residual solvents

Methnol≤0.3%

Tetrahydrofuran≤0.072%

Toluene≤0.089%

Ethyl acetate≤0.5%

Dichloromethane≤0.06%

N.D

N.D

N.D

0.05%

N.D

Puirty(HPLC)

≥97.5%

99.9%

Assay

97.5%~ 102.5%

99.5%