Analysis:
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. |
Specification:
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% |