Category
Seladelpar
CAS Number
NA
Molecular Formula
C24H48O8
Molecular Weight
464.6g/mol
Synonym

(2R,3R,4R,5R)-1,2,3,4,5,6-hexahydroxyhexyl stearate

Keywords
Pharmaceutical Standards
Impurities
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Seladelpar Impurity 17 is a specified related substance observed during the manufacturing, purification, or stability studies of Seladelpar, a selective PPAR-δ agonist used for primary biliary cholangitis (PBC). This impurity can arise from process-related side reactions, residual intermediates, or degradation pathways such as oxidation, hydrolysis, or structural rearrangement under stress conditions. It is identified, structurally characterized, and quantitatively controlled according to ICH Q3A/Q3B guidelines to ensure the drug substance and finished product meet regulatory standards for purity, safety, and quality.