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Active Pharmaceuticals

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  • Specifications
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  • COA

Product Name:Sertraline Hydrochloride
CAS:79559-97-0
MF:C17H18Cl3N
MW:342.69
EINCES:616-702-0
Appearance:white powder

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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