Quick Details:
Alias : (5alpha,17beta)-n-{2,5-bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-l-ene-17-carboxamide,Duagen, Dutasteride, Avodart , GG-745, GI-198745
MF: C27H30F6N2O2
MW: 528.53
CAS: 164656-23-9
MOL: Mol file
Purity: 99.5%
Appearance: white powder.
Description:
A synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT.
Dutasteride is chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4- azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5
Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water.
Usages:
Treating symptoms of benign prostatic hyperplasia (BPH) or enlargement of the prostate gland. It also helps to reduce the risk of urinary blockage and the need for surgery to treat BPH. It may be used alone or along with another medicine (tamsulosin).
Dutasteride is a 5 alpha-reductase enzyme inhibitor. It works by lowering levels of a hormone called dihydrotestosterone (DHT), which is a major cause of prostate growth. Lowering DHT leads to shrinkage of the enlarged prostate gland.
Dutasteride is a medication used to treat benign prostatic hyperplasia (enlarged prostate) and androgenetic alopecia (pattern hair loss).
Medical uses:
Avodart (dutasteride) 500 µg soft capsules
Prostate enlargement
Dutasteride is occasionally used for treating benign prostatic hyperplasia (BPH); colloquially known as an "enlarged prostate". It is approved by the Food and Drug Administration (FDA) in the U.S. for this indication.
Prostate cancer
Pattern hair loss
Dutasteride is approved for the treatment of male androgenetic alopecia in South Korea at a dosage of 0.5 mg per day. It has been found in several studies to improve hair growth in men more rapidly and to a greater extent than 2.5 mg/day finasteride. Dutasteride has also been used off-label in the treatment of female pattern hair loss.
Excessive hair growth:
Although no reports specific to dutasteride currently exist, 5α-reductase inhibitors like finasteride have been found to be effective in the treatment of hirsutism (excessive facial and/or body hair growth) in women. Dutasteride may be more effective than finasteride for this indication due to the fact that its inhibition of the 5α-reductase enzyme is comparatively more complete.
COA:
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Test Items |
Specification |
Test Results |
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Description |
White or off-white crystalline powder |
Off-white crystalline powder |
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|
Specific rotation |
-56°~-60° |
-58.2° |
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|
Identification |
IR |
Matches with working standard |
Complies |
|
HPLC |
|||
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Solubility |
Freely soluble in chloroform and in alcohol; Very slightly soluble in water |
Conform |
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|
Heavy metals |
≤10ppm |
<10ppm |
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Water |
≤0.3% |
0.22% |
|
|
Residue on ignition |
≤0.1% |
0.05% |
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|
Relative material |
Maximum impurities≤0.5% |
0.36% |
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Total impurities≤1.0% |
0.52% |
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Assay |
98.5~101.0% |
99.68% |
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Conclusion |
The specification conform with USP29 |
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