Ursodeoxycholic acid is a bile acid used for the treatment of primary biliary cirrhosis (PBC), dissolution of radiolucent gallstones in patients with a functioning gallbladder, and treatment of hepatobiliary disorders associated with cystic fibrosis in pediatric patients. Ursodeoxycholic acid is an epimer of chenodeoxycholic acid.
Analysis content
|
Specification
|
Analysis results
|
Appearance
|
White or off-white powder
|
conforms
|
Odor
|
Characteristic
|
conforms
|
Assay Fipronil
|
97% min
|
99.68%
|
Ph Value
|
5.0-7.0
|
conforms
|
Loss on Drying
|
≤1%
|
0.12%
|
Heavy Metal
|
<10ppm
|
conforms
|
As
|
<2ppm
|
conforms
|
Residual Solvents
|
Eur.Pharm.
|
conforms
|
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