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Farmaceutice active

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Numele produsului:Sertraline Hydrochloride
CAS:79559-97-0
MF:C17H18Cl3N
MW:342.69
EINCES:616-702-0
Aspect:pulbere albă

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. În 2011, it was the second-most prescribed antidepressant on the U.S. retail market, cu 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.

Articole Caietul de sarcini Rezultate
Aspect White powder of crystalline powder Pulbere cristalină albă
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. Se conformează
UV The UV absorption spectra of the test solution exhibit maximum absorption at 266nm,273nm and 282nm. Se conformează
ŞI IR spectrum of sample conforms to that of reference standard. Se conformează
Reacția clorurilor A solution of it responds to the tests for Chloride. Se conformează
TESTE
Aspectul soluției Clar;not more intensely coloured than Y2 sau GY2 Se conformează
Substanțe înrudite
Impuritatea A NMT 0.2% 0.01%
Impuritatea B NMT 0.2% Nu a fost găsit
Impurity C+D NMT 0.8% 0.02%
Impuritatea F NMT 0.2% Nu a fost găsit
0.03%(RRT:0.95)
Any other detectable impurity NMT 0.1% 0.03%(RRT:1.2)
0.03%(RRT:1.3)
Impurități totale NMT 1.5% 0.15%
Impurity E NMT 0.2% Nu a fost găsit
Enantiomeric NMT 1.0% 0.02%
Solvenți reziduali
metanol NMT 0.3% Nu a fost găsit
Etanol NMT 0.5% 0.0636%
n-Butanol NMT 0.5% Nu a fost găsit
Tetrahydrofuran NMT 0.072% Nu a fost găsit
Toluene NMT 0.089% Nu a fost găsit
Ethyl acetate NMT 0.5% Nu a fost găsit
Ether NMT 0.5% 0.0007%
Chloroben NMT 0.036% Nu a fost găsit
N-methyl formamide NMT 0.088% Nu a fost găsit
Pierdere la uscare NMT 0.5% 0.08%
Rezidu la aprindere NMT 0.1% 0.03%
Metale grele NMT 0.001% Mai puțin decât 0.001%
Test(pe bază anhidră) NLT 98.5% of C17H17Cl2N·HCl 99.6%

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