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分析报告Certificate of Analysis
|
Product Name |
Dutasteride |
CAS NO |
164656-23-9 |
|
Batch No. |
20201001 |
Manufacturing Date |
2020-10-01 |
|
Quantity |
1Kg |
Expiration Date |
2022-09-30 |
|
Item |
Specification |
Result |
|
Appearance |
white or almost white crystalline powder |
Conforms |
|
Assay% |
≥98.5% |
99.4%
|
|
Solubility |
Free soluble in methylene chloride and in methanol;soluble in alcohol;practically insoluble water |
conform |
|
Identification |
Meet the requirements |
conforms |
|
melting point |
242~250℃ |
246.5~248℃ |
|
Mesh size |
30mesh |
conforms |
|
Residual solvent μg/g |
Toluene≤890 |
Conforms |
|
Relative substanc% |
total impurity≤ 1.0 |
0.6 |
|
Loss on drying |
≤ 0.5%
|
0.2 |
|
Residue on ignition |
≤0.2% |
0.02 |
|
Heavy Metals μg/g |
≤20 |
<20 |
Packing and Storage: Packed in paper drums and two plastic bags inside. Store in well closed container away from moisture.


