Category
Seladelpar
CAS Number
NA
Molecular Formula
C48H56F6O14S2
Molecular Weight
1035.1g/mol
Synonym

(2R,3R,4R,5R)-2,3,4,5-tetrahydroxyhexane-1,6-diyl bis(2-(4-(((R)-2-ethoxy-3-(4-(trifluoromethyl)phenoxy)propyl)thio)-2-methylphenoxy)acetate)

Keywords
Pharmaceutical Standards
Impurities
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Seladelpar Impurity 16 is a specified related compound identified during the synthesis or stability testing of Seladelpar, a selective PPAR-δ agonist indicated for primary biliary cholangitis (PBC). This impurity may form due to process-related side reactions, incomplete conversion of intermediates, or degradation pathways such as oxidation, hydrolysis, or structural rearrangement under stress conditions. It is detected, characterized, and controlled as part of impurity profiling in accordance with ICH Q3A/Q3B guidelines to ensure the drug substance maintains required standards of purity, quality, and safety.