|
Items |
Standard |
|
Appearance |
Light yellow to white crystalline powder |
|
Solubility |
Sparingly soluble in water; freely soluble in ethanol(96 %) |
|
Assay |
98.0-102% |
|
Sulfate ash |
≤0.25% |
|
Loss on drying |
≤1.0% |
|
Total impurities |
≤1.0% |
|
Single impurity |
≤0.5% |
Introduction: Pirfenidone (PFD) is a novel pyridone compound with broad-spectrum anti-fibrotic activity, capable of preventing and reversing fibrosis and scar formation. Marketed by Shionogi & Co. of Japan in 2008, it has been approved by the U.S. Food and Drug Administration (FDA) and was the first drug to demonstrate efficacy against idiopathic pulmonary fibrosis (IPF) through repeated, randomized, placebo-controlled Phase III clinical trials. It also shows good efficacy in other fibrotic diseases such as renal interstitial fibrosis and liver fibrosis. Furthermore, it has wide applications in Phase II clinical studies of kidney diseases (focal segmental glomerulosclerosis), hypertrophic cardiomyopathy, adult type I neurofibromatosis, adolescent type I neurofibromatosis and plexiform neurofibromatosis, diabetes mellitus with kidney disease, and uterine leiomyoma.
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