Finasteride Finasteride 98319-26-7 99% Finasteride
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Specification
IEST |
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 |
99.55% |
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% |
0.16% |
Residue on ignition |
≤0.1% |
0.07% |
Heavy metals (Method II) |
≤10 ppm |
Complies |
Chromatographic purity |
Single largest impurity: ≤0.5% |
0.09% |
|
Total impurities: ≤1.0% |
0.28% |
Particle size |
100% < 30 micron |
Complies |
|
90% < 25 micron |
Complies |
Conclusion |
The test product complies with the requirements of USP32. |
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