Seladelpar Methyl Impurity

Seladelpar Methyl Impurity is a process- or degradation-related impurity associated with Seladelpar, a selective PPAR-δ agonist used in primary biliary cholangitis (PBC). This impurity arises when a methyl group is introduced or modified unintentionally during synthesis, side reactions, or degradation pathways such as oxidation or rearrangement. It is structurally characterized and closely monitored because even small amounts can impact the drug’s purity, stability, and safety. Control of this methyl-related impurity follows ICH Q3A/Q3B guidelines to ensure compliance with regulatory standards and maintain high-quality active pharmaceutical ingredient (API).