| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Non-Customized |
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| Items | Specification |
| Description | White or pale-yellow powder |
| Identification | A: Infrared absorption. |
| B: 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, slightly soluble in polyethylene glycol 400, and insoluble in water. |
| Residue on ignition | NMT 0.1% |
| Heavy metals | Not more than 20ppm |
| Water | NMT 0.50% |
| Optical rotation | +15.0° to +25.0° |
| Limit of platinum | NMT 5ug/g |
| Organic impurities procedure 1 |
Dutasteride acid NMT 0.2% |
| Dutasteride dimethylamide NMT 0.2% | |
| Dutasteride methyl ester NMT 0.15% | |
| Dutasteride ethyl ester NMT 0.2% | |
| Dutasteride 17α-5-ene NMT 0.2% | |
| Dutasteride 17α-epimer NMT 0.3% | |
| Chlorodutasteride NMT 0.4% | |
| Dutasteride -5-ene NMT 0.3% | |
| Any other individual impurity NMT 0.1% | |
| Organic impurities procedure 2 |
Dihydrodutasteride NMT 0.15% |
| Dutasteride α-dimer NMT 0.3% | |
| Dutasteride β-dimer NMT0.5% | |
| Any other individual impurity NMT 0.1% | |
| Total impurities NMT 2.0% | |
| Assay (by HPLC, base on drying) | Not less than 97.0% and not more than 102.0% |
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