pirfenidone

Items

Acceptance criteria

Results

Character

Appearance: White or almost white powder.

Almost white powder

Solubility: Slightly soluble in water, freely 

soluble in dilute acetic acid and in methanol, 

slightly soluble in alcohol.

Complies 

Identification

A.Specific optical rotation: –30.0º~-33.5º 

(dried substance)

–33.3º

B.Infrared absorption spectrophotometry:

The IR spectrum is consistent with that 

obtained with Levodropropizine CRS.

Complies 

Tests

pH 

9.2~10.2

9.4

Impurity B and related 

substances

Impurity B: ≤ 0.5%

≤ 0.1%

Any other impurity: ≤ 0.1 %

≤ 0.1%

Total impurities: ≤ 0.6 %

≤ 0.1%

Impurity C

≤ 5 ppm

≤ 5ppm

Enantiomeric purity

Impurity A: ≤  2 %

0.2 %

Loss on drying 

≤ 1.0 %.

≤ 0.1%

Sulphated ash

≤ 0.2 %

≤ 0.1%

Assay

98.5% ~ 101.0%(dried substance)

99.7%

Conclusion 

The product meets the specification of EP7.0