fenofibrate sedufen proctofene
fenofibrate
2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid isopropyl ester; proctofene; sedufen
Items |
Standard |
---|---|
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 |
fenofibrate
2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid isopropyl ester; proctofene; sedufen
Items |
Standard |
---|---|
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 |
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