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Treating urinary problems caused by an enlarged prostate gland (benign prostatic hyperplasia [BPH]). It is also used to lower the risk of needing surgery to treat BPH. It may be used with another medicine (doxazosin) to lower the risk of worsening BPH. It may also be used for other conditions as determined by your doctor.
Finasteride is a type of steroid reductase inhibitor. It works by reducing the amount of the hormone dihydrotestosterone (DHT) in the body. This makes the prostate gland smaller, which helps to relieve urinary problems.
Specification:
|
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 |
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. |
|
Packaging details:
|
Packaging details: |
1 kg/drum with double plastic bags inside; packed in a cardboard drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat. |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
