Identification:
The infrared absorption spectrum of sample is completely in conformity with the spectrum of ursodeoxychloric acid CRS.
The principle spot in the chromatogram obtained with test solution is similar in position, color and size to the principal spot in the chromatogram obtained with reference solution.
Colorimetric Detection: The suspension obtained in greenish-blue.
Appearance:White or Off-white powder
Content≥98.5%
Solubility:Practically insoluble in water, freely soluble in ethanol (96%), slightly soluble in acetone, practically insoluble in methylene chloride.
Melting Point:200℃~ 204℃
Loss on Drying≤1.0%
Optical Rotation:+58.0°~ +62.0°
Heavy Metals≤20PPM
Sulphated Ash≤0.1%
Impurity
Lithocholic acid≤0.1%
Related Substance
Chenodeoxycholic acid≤1.0%
Any unspecified single impurity ≤0.1%
Total impurities ≤1.5%