Pirfenidone

Pirfenidone Impurities & Reference Standards

Pirfenidone is recognized as an active pharmaceutical ingredient (API) that supports formulation development, process validation, and quality assurance in drug manufacturing. Pirfenidone is registered under CAS Number 53179-13-8. It has a molecular formula of C12H11NO and a molecular weight of 185.2 g/mol. Related substances and impurities of Pirfenidone are routinely used as reference materials for stability-indicating method development, impurity profiling, and compliance with ICH, USP, BP, and EP monographs. Each batch of Pirfenidone reference standard is accompanied by a Certificate of Analysis (CoA), HPLC purity data, and spectroscopic (NMR/MS/IR) characterization for use in pharmaceutical laboratories worldwide.