Seladelpar Impurity 13

Seladelpar Impurity 13 is a specified related compound observed during the manufacturing or stability assessment of Seladelpar, a selective PPAR-δ agonist indicated for primary biliary cholangitis (PBC). It generally arises from process-related side reactions, incomplete conversion of intermediates, or degradation pathways such as oxidation or structural rearrangement under stress conditions. As with other identified impurities, it is structurally characterized and quantitatively controlled in accordance with ICH Q3A/Q3B impurity guidelines to ensure the drug substance maintains required standards of purity, safety, and quality.