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Productos farmacéuticos activos

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Nombre del producto:Sertraline Hydrochloride
CAS:79559-97-0
MF:C17H18Cl3N
megavatio:342.69
EINCES:616-702-0
Apariencia:polvo blanco

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 (ISRS) class.Target: SSRISertraline is an antidepressant of the selective serotonin reuptake inhibitor (ISRS) 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. En 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.

Elementos Especificación Resultados
Apariencia White powder of crystalline powder Polvo cristalino blanco
Rotación óptica específica +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. Cumple
ultravioleta The UV absorption spectra of the test solution exhibit maximum absorption at 266nm,273nm and 282nm. Cumple
Y IR spectrum of sample conforms to that of reference standard. Cumple
Reacción de cloruros A solution of it responds to the tests for Chloride. Cumple
PRUEBAS
Aspecto de la solución Claro;not more intensely coloured than Y2 o GY2 Cumple
Sustancias relacionadas
Impureza A no-mt 0.2% 0.01%
Impureza B no-mt 0.2% Extraviado
Impurity C+D no-mt 0.8% 0.02%
Impureza F no-mt 0.2% Extraviado
0.03%(RRT:0.95)
Any other detectable impurity no-mt 0.1% 0.03%(RRT:1.2)
0.03%(RRT:1.3)
Impurezas totales no-mt 1.5% 0.15%
Impurity E no-mt 0.2% Extraviado
Enantiomeric no-mt 1.0% 0.02%
Solventes residuales
Metanol no-mt 0.3% Extraviado
Etanol no-mt 0.5% 0.0636%
n-Butanol no-mt 0.5% Extraviado
Tetrahydrofuran no-mt 0.072% Extraviado
Toluene no-mt 0.089% Extraviado
Ethyl acetate no-mt 0.5% Extraviado
Ether no-mt 0.5% 0.0007%
Chloroben no-mt 0.036% Extraviado
N-methyl formamide no-mt 0.088% Extraviado
Pérdida por secado no-mt 0.5% 0.08%
Residuo de ignición no-mt 0.1% 0.03%
metales pesados no-mt 0.001% Menos que 0.001%
Ensayo(en base anhidra) NLT 98.5% of C17h17Cl2N·HCl 99.6%

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