CAS number： 49562-28-9
Molecular formula： C20H21ClO4
molecular weight： 360.83
Chemical structure：
| Sr No. | Test | Specification | Result | |||
| 1 | Appearance | White or almost white, crystalline powder | White, crystalline powder | |||
| 2 | Solubility | Very soluble in Methylene chloride, slightly soluble in alcohol, practically insoluble in water | Complies | |||
| 3 | Identification by: | |||||
| By IR | The infrared absorption spectrum of sample in Potassium bromide is concordant with that of similar preparation of Fenofibrate RS/WS | The infrared absorption spectrum of sample in Potassium bromide is concordant with that of similar preparation of Fenofibrate RS/WS | ||||
| 4 | Melting Range | Between 80.00C to 81.00C | 79.0C to 82.0C | |||
| 5 | Loss on drying (Under Vacuum at 600C) | Not more than 0.5% w/w | 0.06 % | |||
| 6 | Color and Achromicity | Test solution is not more intensely colored than the Reference | Complies | |||
| 7 | Acidity | Not more than 0.2 mL is required to change the color of the indicator to pink | Complies | |||
| 8 | Residue on Ignition | Not more than 0.1 % w/w | 0.05 % w/w | |||
| 9 | Chloride content | It shows no more than chloride than corresponds to 0.15 mL of 0.020 N Hydrochloride acid (0.01 | Complies | |||
| 10 | Sulfated content | It shows no more than sulfate than corresponds to 0.15 mL of 0.020 N sulfuric acid (0.01%) | Complies | |||
| 11 | Related compound by HPLC | |||||
| Fenofibrate related compound A | Not more than 0.1 % | Not detected | ||||
| Fenofibrate related compound B | Not more than 0.1 % | Not detected | ||||
