Listing ID #4247264
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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. |