Obeticholic Acid Dimer Impurity

Development and validation of stability indicating UPLC-​ELSD detection method for the determination of obeticholic acid in bulk and finished formulations
By Ali, Syed Mastan; Ramachandran, D.
From European Journal of Biomedical and Pharmaceutical Sciences (2021), 8(5), 281-289

Determination of obeticholic acid and its glycine conjugate in human plasma using liquid chromatography-​tandem mass spectrometry
By Ramisetti, Muralikrishna; Atmakuri, Lakshmana Rao; Dachuru, Rama Shekara Reddy
From International Journal of Research in Pharmaceutical Sciences (Madurai, India) (2020), 11(Suppl.4), 2681-2687

Obeticholic Acid Dimer Impurity is chemically 3a(3a,7a-dihydroxy-6a-ethyl-5b-cholan-24-oyloxy)7a-hydroxy-6a- ethyl-5b-cholan-24-oic acid ; (4R)-4-((3R,5S,6R,7R,8S,9S,10S,13R,14S,17R)-6-ethyl-3-(((4R)-4-((3S,6S,7S,8S,9S,10S,13R,14S,17R)-6-ethyl-3,7-dihydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoyl)oxy)-7-hydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoic acid. Obeticholic Acid Dimer Impurity is supplied with detailed characterization data compliant with regulatory guideline. Obeticholic Acid Dimer Impurity 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 Obeticholic Acid.

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.