Seladelpar Impurity 11

Seladelpar Impurity 11 is a specified related substance detected during the manufacture or stability evaluation of Seladelpar, a selective PPAR-δ agonist approved for primary biliary cholangitis (PBC). This impurity typically arises from process-related side reactions, incomplete reactions, or degradation pathways such as oxidation, hydrolysis, or structural rearrangement. As with other numbered impurities, it is identified, characterized, and quantitatively controlled under ICH Q3A/Q3B impurity guidelines to ensure the drug substance maintains acceptable purity, safety, and efficacy throughout its shelf life.