前列地尔

Appearance

 White to off-white crystalline powder

white crystalline powder 

Identification

HPLC retention time of sample complies with that of known sample

Complies

Specifific optical rotation

-60.0°~ -70.0°

-65.0°

Water

≤0.5%

0.18%

Residue on Ignition

≤0.5%

0.15%

Related Substances

Impurity A  ≤1.5%

Impurity B  ≤ 0.5%

Any other impurity ≤ 0.9%

Total impurities ≤1.5%

N.D.

N.D.

N.D.

0.24%

Residual solvents

Ethanol ≤5000ppm

Acetone ≤5000ppm

Dichloromethane ≤600ppm

n-Hexane ≤290ppm

Ethyl acetate ≤5000ppm

n-Heptane ≤5000ppm

505ppm

N.D.

N.D.

N.D.

699ppm

448ppm

Assay

95.0%~102.5%(anhydrous substance)

99.8%