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

Conforms

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%

Conforms

Total Impurities

≤1.5%

0.08%

Any unspecified Impurities

any≤0.07%

Conforms

Sulfate

≤0.05%

Conforms

Residual Solvent

Acetone≤5,000ppm

Isopropanol≤5,000ppm

Triethylamine≤300ppm

Conforms

Chloride

≤0.02%

Conforms

Loss on Drying

≤1.0%

0.10%

Sulfated Ash

≤0.1%

0.01%

Heavy Metal

≤10ppm

Conforms

Transmittance

≥85%

86.4%

Specific Optical Rotation

+58.0? ~  +62.0?

+60.1?