Ursodeoxycholic Acid (UDCA) 128-13-2

Assay (titration)99.0%
SolubilitySoluble in alcohol, Acetone, Methylene chloride
Item
Specification
Result
Appearance
White or almost white powder
Complies
Assay (titration)
≥99.0%
99.8%
Solubility
Soluble in alcohol, Acetone, Methylene chloride
Complies
Identification
IR, TLC and Chrominance test
Complies
Melting point
~202°C
Complies
Specific Optical Rotation
58~62
o

Heavy metals
20ppm

Loss on drying
1.0%
0.08%
Sulphated ash
0.1%
0.05%

Sesidual solvents
Acetone ≤0.5%
0.22%
Methanol≤ 0.3%
Not detected
Secondary butyl alcohol ≤0.5%
Not detected

Related substance(TLC)

Lithocholic acid≤0.1%
Complies
Cholic acid≤0.5%
Complies
CDCA≤1.0%
Complies