fenofibrate CAS NO.49562-28-9

appearance

white or slightly yellow, crystalline powder

solubility

practically insoluble in water, freely soluble in anhydrous ethanol, soluble in toluene.

melting point

116 – 118℃

identification

ir: should be identical to that of rs

appearance of solution

clear, not more than by4

water

≤0.5%

chlorides

≤350ppm

sulphated ash

≤0.1%

related substances

impurity a≤0.1%

impurity b≤0.2%

impurity c≤0.1%

impurity d≤0.1%

impurity e≤0.8%

any other impurity ≤0.1%

total of other impurities ≤0.5%

assay

99%-101%(anhydrous substance)

residual solvents

toluene≤890ppm

hexane≤290ppm