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| TEST | SPECIFICATIONS | RESULTS |
|---|---|---|
| Appearance | White or almost white crystalline powder. Melts at about 257°C | Complies |
| Assay(HPLC, based on drying) | 98.5% ~ 101.0% calculated on anhydrous basis | 0.9955 |
| Identification Infrared Absorption Retention time | Corresponds to spectrum of USP Finasteride RS Retention time of major peak of Assay preparation corresponds to USP Finasteride RS preparation | Corresponds to spectrum ofUSP Finasteride RS Retention time of major peak of Assay preparation corresponds to USP Finasteride RS preparation |
| Specific rotation | -56.0°~ -60.0° | -57.5° |
| Melting Point | Melts at about 257° | complies |
| Solubility | Free soluble in Chloroform and in alcohol,very slightly soluble in water | Complies |
| Water (Method I) | ≤0.3% | 0.0016 |
| Residue on ignition | ≤0.1% | 0.0007 |
| Heavy metals (Method II) | ≤10 ppm | Complies |
| Chromatographic purity | Single largest impurity: ≤0.5% | 0.0009 |
| Total impurities: ≤1.0% | 0.0028 | |
| Particle size | 100% < 30 micron | Complies |
| 90% < 25 micron | Complies | |
| Conclusion | The test product complies with the requirements of USP32. | |
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