Ursodeoxycholic Acid EP Impurity B

A validated RP-HPLC method for quantitative determination of related impurities of ursodeoxycholic acid (API) by refractive index detection
Ashok Peepliwal, C.G.Bonde, K.G.Bothara
Journal of Pharmaceutical and Biomedical Analysis Volume 54, Issue 4, 25 March 2011, Pages 845-849
 
Determination of Chenodeoxycholic Acid in Pharmaceutical Preparations of Ursodeoxycholic Acid by High Performance Liquid Chromatography with Coulometric Electrochemical Detection
E. Bousquet, N. A. Santagati & S. Tirendi
Journal of Liquid Chromatography & Related Technologies  Volume 20, 1997 - Issue 5 Pages 757-770
 
Validated High-performance Liquid Chromatography Method for Degradation Study of Ursodeoxycholic Acid and Silymarin
Imran A. Sheikh, Manoj Charde , Abhilasha Mittal
International Journal of Pharmaceutical & Biological Archives 2018; 9(3):73-77

Ursodeoxycholic Acid EP Impurity B is chemically 3α,7α,12α-Trihydroxy-5β-cholan-24-oic acid. It is also known as Cholic Acid ; Chenodeoxycholic Acid EP Impurity B ; . Ursodeoxycholic Acid EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Ursodeoxycholic Acid EP Impurity B can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Ursodeoxycholic.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.