Description

Pirfenidone CAS NO 53179-13-8 is a small molecule pharmaceutical agent belonging to the pyridone class. It is a critical active pharmaceutical ingredient (API) valued for its potent anti-fibrotic and anti-inflammatory properties. This compound is essential for pharmaceutical manufacturers developing treatments for fibrotic diseases, particularly idiopathic pulmonary fibrosis (IPF).

Application

• Pharmaceutical API: Primary use as the active ingredient in oral formulations for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
• Clinical Research: Used in investigational new drugs (INDs) for studying its efficacy in other fibrotic conditions such as liver cirrhosis, renal fibrosis, and cardiac fibrosis.
• Generic Drug Manufacturing: Sourced by generic pharmaceutical companies for the production of bioequivalent versions of approved pirfenidone medications.
• Drug Discovery & Development: Serves as a reference standard or a lead compound in research programs targeting TGF-β mediated pathways.
• Formulation Development: Utilized in R&D for developing novel drug delivery systems, including controlled-release tablets and capsules.

Basic Information

Item	Details
Product Name	Pirfenidone
CAS No.	53179-13-8
Molecular Formula	C₁₂H₁₁NO
Molecular Weight	185.22 g/mol
Synonyms	5-Methyl-1-phenyl-2(1H)-pyridone; 5-Methyl-1-phenylpyridin-2(1H)-one; AMR69; Deskar; Etuary; Pirespa; Pirfenex; Shionogi-101; Ebrave
EINECS	Contact for details

Quality Control

Our Pirfenidone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity pharmaceutical standards, including identity, purity, and impurity profile verification. Certificates of Analysis (COA) documenting compliance with relevant specifications are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, protect from moisture. Keep container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 0.5%
Sulfated Ash	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.