Item | Specification |
Appearance | White or slightly brown or yellow powder |
Solubility | Slightly soluble in water Freely soluble in anhydrous ethanol Practically insoluble in heptanes. |
Identification | Test A: By Infrared absorption spectrophotometry |
Test B: the retention time of the major peak of the sample solution corresponds to that of the standard solution. | |
Test C: by chloride test | |
Organic impurities | 7-Methyl vardenafil: ≤0.15% |
Vardenafil acid: ≤0.10% | |
Vardenafil dimer: ≤0.10% | |
Any unspecific impurities: ≤0.10% | |
Total impurities: ≤0.30% | |
Water | 8.8%-10.5% |
Residue on ignition | ≤0.10% |
Assay by HPLC | 98.0% to 102.0% (anhydrous basis) |