98319-26-7 Finasteride proscar
Product Name: Finasteride
CAS No.: 98319-26-7
EINECS: 620-534-3
Molecular Formula: C23H36N2O2
Molecular Weight: 372.54
Appearance: white powder
ITEM |
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 |
99.55% |
anhydrous basis |
||
Identification |
||
Infrared |
Corresponds to spectrum of |
Corresponds to spectrum ofUSP Finasteride RS |
Absorption |
USP Finasteride RS |
|
Retention time of major |
||
Retention |
Retention time of major peak |
peak of Assay preparation |
time |
of Assay preparation |
corresponds to USP |
corresponds to USP Finasteride |
Finasteride RS preparation |
|
RS preparation |
||
Specific rotation |
-56.0°~ -60.0° |
-57.5° |
Melting Point |
Melts at about 257° |
complies |
Solubility |
Free soluble in Chloroform and |
Complies |
in alcohol,very slightly soluble |
||
in water |
||
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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