Pirfenidone

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2 Hydroxy-5-methylpyridine-N-Oxide

  • CAT NUMBER DCTI-C-591
  • CAS NUMBER 181235-23-4
  • MOLECULAR FORMULA C6H7NO2
  • MOLECULAR WEIGHT 125.13

5-methyl-N-phenyl pyridine-2-amine

  • CAT NUMBER DCTI-C-714
  • CAS NUMBER 43191-23-7
  • MOLECULAR FORMULA C12H12N2
  • MOLECULAR WEIGHT 184.24

Pirfenidone EP Impurity A

  • CAT NUMBER DCTI-C-2654
  • CAS NUMBER 1603-41-4
  • MOLECULAR FORMULA C6H8N2
  • MOLECULAR WEIGHT 108.14

Pirfenidone EP Impurity B

  • CAT NUMBER DCTI-C-2655
  • CAS NUMBER 1003-68-5
  • MOLECULAR FORMULA C6H7NO
  • MOLECULAR WEIGHT 109.13

Pirfenidone PIRRC-11

  • CAT Number DCTI-C-1710
  • CAS Number NA
  • Molecular Formula C18H16N2O2
  • Molecular Weight 292.34

Pirfenidone-D3

  • CAT NUMBER DCTI-A-206
  • CAS NUMBER 1093951-85-9
  • MOLECULAR FORMULA C12H8D3NO
  • MOLECULAR WEIGHT 188.24

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 ActionPirfenidone 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.

References
FAQ's

Frequently Asked Questions

Rigorous purification techniques help minimize Pirfenidone impurities significantly and ensure its quality.

Pirfenidone impurities analysis verifies the drug's purity, safety, and efficacy in treating lung illnesses and fibrosis.

The synthetic process of Pirfenidone impurities involves specific chemical reactions and methods during the manufacturing of the drug.

Pirfenidone impurities should ideally be stored at a controlled room temperature of 2-8°C or as described on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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