Category
Seladelpar
CAS Number
NA
Molecular Formula
C27H35F3O10S
Molecular Weight
608.6g/mol
Synonym

(2R,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl 2-(4-(((R)-2-ethoxy-3-(4-(trifluoromethyl)phenoxy)propyl)thio)-2-methylphenoxy)acetate

Keywords
Pharmaceutical Standards
Impurities
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Seladelpar Impurity 15 is a designated related substance detected during the manufacturing process or stability evaluation of Seladelpar, a selective PPAR-δ agonist used in the treatment of primary biliary cholangitis (PBC). It may arise from process-related side reactions, residual starting materials, intermediates, or degradation pathways such as oxidation or structural transformation under stress conditions. Like other specified impurities, it is identified, structurally characterized, and quantitatively controlled according to ICH Q3A/Q3B guidelines to ensure the drug substance and finished product meet required standards for purity, safety, and regulatory compliance.