Items
Specifications
Results
Description
White or off-white crystalline powder
Conform
Identification
HPLC, HNMR,IR
Specific rotation
[α]20D: - 42.0º ~ - 48.0º
- 42.5º ~ - 47.3º
Water
< 0.5 %
0.21 %
Limit of related substance
Lubiprostone A≤0.1 %
0.05%
Any unknown impurity
≤0.1 %
0.09%
Total impurities
≤0.5 %
0.30%
Residue on Ignition
≤ 0.1%
0.04%
Residue Solvent
Pentane ≤5000ppm
Ethyl acetate≤1000ppm
Acetonitrile≤400ppm
Diisopropyl ether≤500ppm
Hexane≤150ppm
Dichloromethane≤500ppm
Assay (on anhydrous substance)
98.00 % to 102.00 %
99.50%
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