Fenofibrate

CAS number: 49562-28-9

Molecular formula: C20H21ClO4

molecular weight: 360.83

Chemical structure:

Sr No.TestSpecificationResult
1AppearanceWhite or almost white, crystalline
powder
White, crystalline powder
2SolubilityVery soluble in Methylene chloride, slightly soluble in alcohol, practically insoluble in waterComplies
3Identification by:

By IRThe infrared absorption spectrum of sample in Potassium bromide is concordant with that of similar preparation of Fenofibrate RS/WSThe infrared absorption spectrum of sample in Potassium bromide is concordant with that of similar preparation of Fenofibrate RS/WS
4Melting RangeBetween 80.00C to 81.00C79.0C to 82.0C
5Loss on drying
(Under Vacuum at 600C)
Not more than 0.5% w/w0.06 %
6Color and AchromicityTest solution is not more intensely colored than the ReferenceComplies
7AcidityNot more than 0.2 mL is required to change the color of the indicator to pinkComplies
8Residue on IgnitionNot more than 0.1 % w/w0.05 % w/w
9Chloride contentIt shows no more than chloride than corresponds to 0.15 mL of
0.020 N Hydrochloride acid (0.01
Complies
10Sulfated contentIt shows no more than sulfate than corresponds to 0.15 mL of 0.020 N
sulfuric acid (0.01%)
Complies
11Related compound by HPLC

Fenofibrate related compound ANot more than 0.1 %Not detected

Fenofibrate related compound BNot more than 0.1 %Not detected