| Elementos |
Especificación |
| pH |
3.5-4.5 |
| Identificación |
1, red to dark purple color appears |
|
con(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 |
| Punto de fusion |
139-143 celcius degree |
| Clarity and color of solution |
clear and colorless |
| Sulfato |
0.048%máximo |
| Metales pesados |
10ppm max |
| As |
2ppm max |
| Organic acid(0.1M NaOH) |
0.54ml max |
| Pérdida por secado |
0.5% máximo |
| Residuos en ignición |
0.1%máximo |
| Residual organic Solvents (CG) |
Xylol 0.217%max |
|
Isopropanol 0.5%max |
| Related substances(HPLC) |
Total impurity 1.5%max |
|
Single impurity0.5%max |
|
Free P-chloro phenoxy acetic 0.5%max |
| Count of bacteria |
bacillus 1000/1g max |
|
Mildew 100/1g max |
|
Microzyme 100/1g max |
| Ensayo(C12H16CINO3.HCl,on dry basis) |
98%min |
Solicitud
HSDD is the most commonly reported form of female sexual dysfunction. HSDD is defined as a persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty, and which is not better accounted for by a medical, substance-related , psychiatric (e.g., depression) or other sexual condition. The cause of HSDD is believed to involve a multitude of social, psychological and biological factors and may be attributed to a complex interplay of these factors.
Flibanserin is a novel, nonhormonal drug that has been studied in clinical trials for the treatment of HSDD in premenopausal and postmenopausal women. The application submitted to the FDA is for premenopausal women.
Flibanserin is believed to work on key neurotransmitters, or chemicals, in the brain that affect sexual desire. Más específicamente, it is thought that flibanserin corrects an imbalance of levels of these neurotransmitters by increasing dopamine and norepinephrine (both responsible for sexual excitement) and decreasing serotonin (responsible for sexual inhibition). In clinical studies, flibanserin was evaluated for its ability to increase the frequency of satisfying sexual events, increase the intensity of sexual desire and decrease the associated distress women feel from its loss.
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