Product Brief Introduction
Product name: Dutasteride
CAS：164656-23-9
MF: C27H30F6N2O2
MW: 528.530
Product Specification
|
Item |
Specification |
|
Appearance |
White to pale yellow powder |
|
Identification |
IR: The infrared absorption spectrum of the sample complies with the reference standard. |
|
HPLC:The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. |
|
|
Solubility |
Soluble in ethanol and methanol,slightly soluble in polyethylene glycol 400,and insoluble in water |
|
Moisture |
≤ 0.5% |
|
Specific Rotation |
+15.0°~ +25.0° |
|
Residue on Ignition |
≤ 0.1% |
|
Heavy Metals |
≤ 20ppm |
|
Limit of Platinum |
≤ 5ug/g |
|
Residual Solvents |
Acetonitrile ≤ 0.3% |
|
Ethyl acetate ≤ 0.2% |
|
|
Dioxane≤ 0.1% |
|
|
n-Heptane≤ 0.5% |
|
|
Toluene ≤ 0.2% |
|
|
Pyridine ≤ 0.2% |
|
|
Organic Impurities Procedure 1 |
Dutasteride acid≤ 0.2% |
|
Dutasteride dimethylamide≤ 0.2% |
|
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Dutasteride methyl ester≤ 0.15% |
|
|
Dutasteride methyl ester≤ 0.2% |
|
|
Dutasteride 17α-5 ene≤ 0.3% |
|
|
Any other individual impurity ≤ 0.1% |
|
|
Organic Impurities Procedure 1 |
Dihydrodutasteride≤ 0.15% |
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Dutasteride α-dimer ≤ 0.3% |
|
|
Dutasteride p-dimer≤ 0.5% |
|
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Any other individual impurity≤ 0.1% |
|
|
Total impurities≤ 2.0% |
|
|
Residual Solvents |
Methanol≤ 3000ppm |
|
Dichloromethane≤ 600ppm |
|
|
Chloroform ≤ 60ppm |
|
|
DMF≤ 880ppm |
|
|
Assay (on dried basis) |
97.0%-102.0% |
