Tadalafil raw powders Tadalafil raw powders Tadalafil raw powders
Name | Tadalafil powder |
Appearence | White crystalline powder |
Cas |
171596-29-5 |
Assay | ≥99.5% |
Solubility | Insoluble in water or alcohol, soluble in Acetic acid, ethyl ester |
Melting point |
300-303°C |
Loss on drying |
≤0.5% |
Heavy Metal |
≤10ppm |
Specific rotation |
[a]20D=+70-72o(C=1.00,CHCl3) |
Dosage |
20-40mg |
Onset time |
30 minites |
Grade |
Pharmaceutical Grade |
Package | 1 kg in an aluminum foil bag, 25kg/drum. |
Items | Specification | Results |
Appearance | White or almost white powder | White powder |
Solubility | Practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride | conform |
Identification | IR,UV | Positive |
Special optical rotation (dried substance) | 78.0 to +84.0 | 81.0° |
Impurities A, B and C | Impurity A: ≤0.15% | 0.01% |
Specified impurities: ≤0.10% | conform | |
relative substance | Unspecified impurities: ≤0.10% | 0.09% |
Total impurity: ≤0.3% | 0.17% | |
Loss on drying | ≤0.5% | 0.20% |
Sulfated ash | ≤0.1% | 0.06% |
Assay (on dried basis) | 97.5%~102% |
99.57% |
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