Items
Specification
Results
Assay
99.0% - 101.0%
100.43%
Appearance
White or off white powder
White powder
Melting point
200℃~204℃
200.7~203.2℃
Impurity A
≤1.0%
0%
Impurity C
≤0.1%
Conforms
Identification
Same IR spectrum as RS
The spot is similar in position with the reference spot
Add formaldehyde,The suspension obtained is greenish-blue
HPLC
≥98.5%
99.92%
22-ene-UDCA
≤1.0%(Area %)
None
Other impurities
(B,D,E,F,G,H)
any≤0.07%
Total Impurities
≤1.5%
0.08%
Any unspecified Impurities
Sulfate
≤0.05%
Residual Solvent
Acetone≤5,000ppm
Isopropanol≤5,000ppm
Triethylamine≤300ppm
Chloride
≤0.02%
Loss on Drying
0.10%
Sulfated Ash
0.01%
Heavy Metal
≤10ppm
Transmittance
≥85%
86.4%
Specific Optical Rotation
+58.0˚ ~ +62.0˚
+60.1˚
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