
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% |