Seladelpar Impurity 14

Seladelpar Impurity 14 is a specified related impurity identified during the synthesis, purification, or stability studies of Seladelpar, a selective PPAR-δ agonist indicated for primary biliary cholangitis (PBC). This impurity may originate from side reactions in the manufacturing process, residual 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 meets required standards of purity, safety, and quality.