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|PH:||3.5-4.5||Appearance:||White Crystals Or Crystalline Powder|
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167933-07-5 Sex Enhancement Drugs 99% Assay Flibanserin for Pre-menopausal Women
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1) Flibanserin Details
Flibanserin;Bimt 17;Filbanserin;Flibanerins; 3-[2-[4-[4-(Trifluoromethyl)phenyl]piperazin-1-yl]ethyl]-1H-benzimidazol-2-one
|Solubility||Freely soluble in water and 95%ethanol, sparingly soluble in acetic anhydride and practically insoluble in diethyl ether|
|Usage||Adrug being studied as a non-hormonal treatment for pre-menopausal women with hypoactive sexual desire disorder (HSDD).|
2) Flibanserin Application
A new drug designed to boost sexual desire in women is controversial for some and eagerly awaited by others, but it's hit a potentially serious snag. The drug didn't boost women's desire any more than a placebo in two clinical trials. The Food and Drug Administration posted the clinical trial results on its website today in advance of a committee meeting on Friday, when a panel of experts will vote whether or not to recommend approval of the drug called flibanserin. (The FDA usually follows the recommendations of its expert panels. ) Although there was a slight increase in the number of sexually satisfying events flibanserin users had each month, the FDA staff who reviewed the results said the so-called response rate isn't "particularly compelling. "It's called the "little pink pill, " a tiny tablet that could have a huge impact on treating female sexual dysfunction. If it's approved, it would become the first drug of its kind on the market.
3) Flibanserin COA
|Appearance||white crystals or crystalline powder, has a faint, characteristic odor and bitter taste|
|Identification||1, red to dark purple color appears with(III)iron chloride|
|2, light red precipitate formed with reinecke salt TS|
|3, UV spectrum meet the reference|
|4, solution (1%) responds to the qualitative test for chloride|
|Melting point||139-143 celcius degree|
|Clarity and color of solution||clear and colorless|
|Heavy metals||10ppm max|
|Organic acid(0.1M NaOH)||0.54ml max|
|Loss on drying||0.5% max|
|Residue on ignition||0.1%max|
|Residual organic Solvents (GC)||Xylol 0.217%max|
|Related substances(HPLC)||Total impurity 1.5%max|
|Free P-chloro phenoxy acetic 0.5%max|
|Count of bacteria||bacillus 1000/1g max|
|Mildew 100/1g max|
|Microzyme 100/1g max|
|Assay(on dry basis)||98%min|
4) Medical Uses
Flibanserin is used for hypoactive sexual desire disorder among women. Those receiving flibanserin report a 0.5 increase compared to placebo in the number of times they had “satisfying sexual events”. In those on flibanserin it rose from 2.8 to 4.5 times a month while women receiving placebo reported also an increase of “satisfying sexual events” from 2.7 to 3.7 times a month. The onset of the flibanserin effect was seen from the first timepoint measured after 4 weeks of treatment and maintained throughout the treatment period.
The effectiveness of flibanserin was evaluated in three phase 3 clinical trials. Each of the three trials had two co-primary endpoints, one for satisfying sexual events (SSEs) and the other for sexual desire. Each of the 3 trials also had a secondary endpoint that measured distress related to sexual desire. All three trials showed that flibanserin produced an increase in the number of SSEs and reduced distress related to sexual desire. The first two trials used an electronic diary to measure sexual desire, and did not find an increase. These two trials also measured sexual desire using the Female Sexual Function index (FSFI) as a secondary endpoint, and an increase was observed using this latter measure. The FSFI was used as the co-primary endpoint for sexual desire in the third trial, and again showed a statistically significant increase.
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