Felodipine Flodil Felodipina
≥99.0%
Felodipine
Appearance |
White to Light yellow tcrystalline powder |
Solubility |
very soluble in Acetone , in Methanol and Ethanol;practically insoluble in water |
Melting point |
141~145℃ |
Identification |
Positive |
|
UV :Maximal absorption should be at 238+2nm and 361+2nm |
|
IR:the IR absorption spectrum of sample corresponds to that of the reference one |
Clarity and color of solution |
The solution is clear and colorless and any color produced ,the absorption of the solution at 440 nm is not more than 0.10 |
Chloride |
≤0.005% |
Loss on drying |
≤0.5% |
Residue on ignition |
≤0.1% |
Heavy metals |
≤0.001% |
Arsenic |
≤0.0002% |
Related substance |
Impurity I ≤0.1% The sum of impurityB and C ≤1.0% Any individual impurity ≤0.5% Total impurities ≤1.0% |
Residual solvents |
Ethanol ≤0.5% Isopropyl ether ≤0.5% Dichloromethane ≤0.5% Ethyl acetate≤0.06% Pyridine ≤0.02% |
Assay |
≥99.0%( calculated on dried basis) |
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