Challenge: The technological objective of this project was to investigate the peak purity of Ursodeoxycholic Acid drug substance and drug product with forced degradation by employing Ultra Performance Liquid Chromatography/Mass Spectrometry (UPLC/MS) techniques.
Ursodeoxycholic acid (UDCA) is one of the secondary bile acids, which are metabolic by-products of intestinal bacteria. Essentially, Diteba was committed to investigate the degradation pathways and impurity profiles of Ursodeoxycholic Acid drug product by assessing the Ursodeoxycholic Acid peak purity by using a UPLC coupled with Mass Spectrometry (MS)…
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- impurity profile of UDCA
- forced degradation ursodeoxycholic acid
- ursodeoxycholic acid forced degradation study
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