Pirfenidone

General Information

Pirfenidone Impurities and Pirfenidone

Daicel Pharma offers Pirfenidone impurity standards such as Pirfenidone PIRRC-11, Pirfenidone EP Impurity A, Pirfenidone EP Impurity B, and 2 Hydroxy-5-methylpyridine-N-Oxide. Their presence can affect the effectiveness, stability, and safety of Pirfenidone. Daicel Pharma can synthesize custom Pirfenidone impurities following global standards and regulations while delivering them worldwide.

Pirfenidone [CAS: 53179-13-8] is a pyridinone derivative and an anti-inflammatory medication to treat idiopathic pulmonary fibrosis. It functions as a non-narcotic analgesic, antipyretic, and non-steroidal anti-inflammatory medicine.

Pirfenidone: Use and Commercial Availability 

Pirfenidone treats idiopathic pulmonary fibrosis (IPF), a chronic, progressive type of interstitial pneumonia. This drug is available under the tradename of Esbriet.

Pirfenidone Structure and Mechanism of Action

The chemical name of Pirfenidone is 5-Methyl-1-phenyl-2(1H)-pyridinone. Its chemical formula is C₁₂H₁₁NO, and its molecular weight is approximately 185.22 g/mol.

The mechanism of action of Pirfenidone is not known.

Pirfenidone Impurities and Synthesis 

Pirfenidone is a drug to treat fibrosis. Impurities may form or be introduced during the production and storage of the drug, affecting its quality, effectiveness, and safety. Pirfenidone synthesis¹ includes several processes, and impurities might form at any point. Related chemicals, leftover starting ingredients, reaction byproducts, and degradation products are types of Pirfenidone impurities.

Daicel provides a Certificate of Analysis (CoA) of Pirfenidone impurity standards, including Pirfenidone PIRRC-11, Pirfenidone EP Impurity A, Pirfenidone EP Impurity B, and 2 Hydroxy-5-methylpyridine-N-Oxide. Daicel Pharma, with its analytical facility certified under current Good Manufacturing Practices (cGMP), offers a comprehensive Certificate of Analysis (CoA) that provides detailed characterization information, including 1H NMR, 13C NMR, IR, MASS, and HPLC purity². Additionally, by request, Daicel Pharma can provide further characterization details like 13C-DEPT. We have the technical capabilities to synthesize Pirfenidone impurities and labeled compounds to facilitate the evaluation of generic Pirfenidone. Furthermore, Daicel Pharma offers Pirfenidone-D3, a deuterium-labeled Pirfenidone standard, for bioanalytical studies and Bioavailability/Bioequivalence (BA/BE) research.