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Active Pharmaceuticals

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  • Specifications
  • Product Description
  • Product Syntaxis
  • COA

Product Name:Sertraline Hydrochloride
CAS:79559-97-0
MF:C17H18Cl3N
MW:342.69
EINCES:616-702-0
Aspectus:cerussa

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 inordinatio (OCD), body dysmorphic disorder (BDD), posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), panic disorder and social phobia (socialis anxietatem inordinatio). 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 Proventus
Aspectus White powder of crystalline powder Album pulveris crystallini
Imprimis gyrationis optica +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. Obsequitur
UV The UV absorption spectra of the test solution exhibit maximum absorption at 266nm,273nm and 282nm. Obsequitur
ET' IR spectrum of sample conforms to that of reference standard. Obsequitur
Reactio chlorides A solution of it responds to the tests for Chloride. Obsequitur
TESTS'
Solutio specie Patet;not more intensely coloured than Y2 aut gy2 Obsequitur
Substantiae cognatae
immunditiam A NMT 0.2% 0.01%
impudicitia B NMT 0.2% Non inveni
Impurity C+D NMT 0.8% 0.02%
immunditia F NMT 0.2% Non inveni
0.03%(RRT:0.95)
Any other detectable impurity NMT 0.1% 0.03%(RRT:1.2)
0.03%(RRT:1.3)
Summa immunditiae NMT 1.5% 0.15%
immunditia E NMT 0.2% Non inveni
Enantiomeric NMT 1.0% 0.02%
RELICTUM menstrua
Methanol NMT 0.3% Non inveni
Ethanol NMT 0.5% 0.0636%
n-Butanol NMT 0.5% Non inveni
Tetrahydrofuran NMT 0.072% Non inveni
Toluene NMT 0.089% Non inveni
Ethyl acetate NMT 0.5% Non inveni
Ether NMT 0.5% 0.0007%
Chloroben NMT 0.036% Non inveni
N-methyl formamide NMT 0.088% Non inveni
Damnum in siccitate NMT 0.5% 0.08%
Requiesce in ignitio NMT 0.1% 0.03%
Metalla gravis NMT 0.001% Minus quam 0.001%
Assay(in anhydrous basis) NLT 98.5% of C17H17Cl2N·HCl 99.6%

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