Seladelpar Impurity 12

Seladelpar Impurity 12 is a designated related substance identified during the synthesis or stability testing of Seladelpar, a selective PPAR-δ agonist used in the treatment of primary biliary cholangitis (PBC). This impurity may form due to side reactions in the manufacturing process or through degradation pathways such as oxidation, hydrolysis, or structural modification under stress conditions. Like other specified impurities, it is characterized and tightly controlled according to ICH Q3A/Q3B guidelines to ensure the drug substance and finished product meet regulatory standards for purity, quality, and patient safety.