| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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Sertraline hydrochloride is a selective serotonin reuptake inhibitor, similar mechanistically to fluoxetine, introduced initially for the maintenance and long-term treatment of depression. It is reportedly non-sedating and compared to fluoxetine has a shorter duration of action and lack of CNS activating effects such as nervousness and anxiety. Sertraline hydrochloride is currently undergoing investigation for the treatment of obesity and obsessive-compulsive disorders.
Sertraline hydrochloride is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.Target: SSRISertraline is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It was introduced to the market by Pfizer in 1991. Sertraline is primarily prescribed for major depressive disorder in adult outpatients as well as obsessive-compulsive, panic, and social anxiety disorders in both adults and children. In 2011, it was the second-most prescribed antidepressant on the U.S. retail market, with 37,208,000 prescriptions.Sertraline is used for a number of conditions including: major depression, obsessive-compulsive disorder (OCD), body dysmorphic disorder (BDD), posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), panic disorder and social phobia (social anxiety disorder). It has also been used for premature ejaculation and vascular headaches but evidence of the effectiveness in treating those conditions is less robust.
| Items | Specification | Results |
| Appearance | White powder of crystalline powder | White crystalline powder |
| Specific optical rotation | +36°~+43° | +41.0° |
| IDENTIFICATION | ||
| HPLC | The retention time of the major peak of the sample solution corresponds to that of the system suitability solution,as obtained in the test for Enatiomeric. | Complies |
| UV | The UV absorption spectra of the test solution exhibit maximum absorption at 266nm,273nm and 282nm. | Complies |
| IR | IR spectrum of sample conforms to that of reference standard. | Complies |
| Reaction of chlorides | A solution of it responds to the tests for Chloride. | Complies |
| TESTS | ||
| Appearance of solution | Clear;not more intensely coloured than Y2 or GY2 | Complies |
| Related substances | ||
| Impurity A | NMT 0.2% | 0.01% |
| Impurity B | NMT 0.2% | Not found |
| Impurity C+D | NMT 0.8% | 0.02% |
| Impurity F | NMT 0.2% | Not found |
| 0.03%(RRT:0.95) | ||
| Any other detectable impurity | NMT 0.1% | 0.03%(RRT:1.2) |
| 0.03%(RRT:1.3) | ||
| Total impurities | NMT 1.5% | 0.15% |
| Impurity E | NMT 0.2% | Not found |
| Enantiomeric | NMT 1.0% | 0.02% |
| Residual solvents | ||
| Methanol | NMT 0.3% | Not found |
| Ethanol | NMT 0.5% | 0.0636% |
| n-Butanol | NMT 0.5% | Not found |
| Tetrahydrofuran | NMT 0.072% | Not found |
| Toluene | NMT 0.089% | Not found |
| Ethyl acetate | NMT 0.5% | Not found |
| Ether | NMT 0.5% | 0.0007% |
| Chloroben | NMT 0.036% | Not found |
| N-methyl formamide | NMT 0.088% | Not found |
| Loss on drying | NMT 0.5% | 0.08% |
| Residue on ignition | NMT 0.1% | 0.03% |
| Heavy metals | NMT 0.001% | Less than 0.001% |
| Assay(on anhydrous basis) | NLT 98.5% of C17H17Cl2N·HCl | 99.6% |
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