Pirfenidone

Pirfenidone (INN, BAN) is an anti-fibrotic drug for the treatment of idiopathic pulmonary fibrosis (IPF). It works by reducing lung fibrosis through downregulation of the production of growth factors and procollagens I and II.

It is a drug developed by several companies worldwide, including the original patent holder, Marnac, Inc., InterMune Inc. (now part of Roche), Shionogi Ltd., and GNI Group Ltd. In 2008, it was first approved in Japan for the treatment of IPF after clinical trials, under the trade name of Pirespa by Shionogi & Co. In October 2010, the Indian Company Cipla launched it as Pirfenex. In 2011, it was approved for use in Europe for IPF under the trade name Esbriet; it was approved in Canada in 2012 under the trade name Esbriet; and was approved in the United States in October 2014 under the same name. In September 2011, the Chinese State Food and Drug Administration provided GNI Group Ltd with new drug approval of pirfenidone in China, and later manufacture approval in 2013 under the trade name of Etuary.

In 2014 it was approved in Mexico under the name KitosCell LP, indicated for pulmonary fibrosis and liver fibrosis. There is also a topical form created for the treatment of abnormal wound healing processes.

Product Name: Pirfenidone

Synonyms: 5-methyl-1-phenyl-2(1h)-pyridon;amr-69;PIRFENIDONE;5-METHYL-1-PHENYL-1H-PYRIDIN-2-ONE;5-METHYL-1-PHENYL-2(1H)-PYRIDINONE;5-METHYL-1-PHENYL-2-(1H)-PYRIDONE;5-Methyl-N-phenyl-2-1H-pyridone;Pirfenidone also see 5-Methyl-1-Phenyl-2(1H)-Pyridinone

CAS: 53179-13-8

MF: C12H11NO

MW: 185.22

EINECS:

Product Categories: Aromatics Compounds;Aromatics;Heterocycles;Intermediates & Fine Chemicals;Pharmaceuticals;Cytokine signaling;Inhibitors

mp 96-97°C

storage temp. Store at RT

solubility DMSO: ≥10 mg/mL, soluble

form solid

Chemical Properties Off-White Solid

Usage Pirfenidone has demonstrated activity in multiple fibrotic conditions, including those of the lung, kidney and liver .

Specification:

Product name	Pirfenidone
batch No.	1407101		CAS No.		53179-13-8
Quantity	2 kg		Manufacture Date		2014.07.08
Report Date	2014.07.09		Expiry Date		2016.06
Based on test	Factory standard
Result of Analysis
Items		Specifications		Results
Appearance		White or almost white crystalline powder		Meets the requirements
Identification		Meets the requirements		Meets the requirements
Melting point		106℃-108℃		107.3℃-108℃
Water (K.F)		Not more than 0.5%		0.09%
2-hydroxy-5-picoline		Not more than 0.15%		None
Any other unspecified		Not more than 0.1%		0.03%
Total impurity		Not more than 0.5%		0.05%
Bromobenzene		Not more than 0.036%		0.01%
Ethyl acetate		Not more than 0.5%		None
Heavy metal		Not more than 20ppm		Less than 20ppm
R0l		Not more than 0.1%		Less than 0.1%
Assay		Not less than 98.0%		99.5%
Conclusion		Comply with the requirements.

Application: 

    The product is used as chemical reagents, organic intermediates, fine chemicals, pharmaceutical research and 

development.

    Mainly used for the new anti fibrosis raw materials. Has a broad spectrum of lung, liver, kidney, heart, and peritoneal

fibrosis action.

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Notice: This product is only suitable for laboratory use, or the use of animals. It can not be used directly on the human body