Product name |
Sertraline Hydrochloride |
CAS No. |
79559-97-0 |
Outer Packing |
25kg/drum |
Production date |
20170525 |
Shelf life |
20190524 |
Standard adopted |
USP |
Items of analysis |
Specification |
Results |
Characteristics |
white or almost white powder |
white powder |
(°)
Speclfic optical rotation |
+37.5~+40.5 |
+39.5 |
Identification |
Positive |
Complies |
solubility of solution and colout |
Complies |
Complies |
Related impurities |
≤1.0 |
0.1 |
Loss on drying |
≤1.0 |
0.1 |
Residue on ignition |
≤0.2 |
0.04 |
heavy metals |
≤20 |
<20 |
Assay |
≥98.5 |
99.1 |
Residual solvent |
≤5000 |
191 |
Conclusion |
Qualified |
Abstract
Sertraline HCL is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs).
The way the drug works is not yet fully understood. Is thought to positively affect the communication between the nerve cells of the central nervous system and / or restore the chemical balance in the brain.
Sertraline for the treatment of depression, obsessive-compulsive disorder, panic disorder, anxiety, post-traumatic stress disorder (PTSD) and premenstrual anxiety (PMDD).
Application
Sertraline is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. Sertraline is primarily prescribed for major depressive disorder in adult outpatients as well as obsessive-compulsive disorder, panic disorder, and social anxiety disorder, in both adults and children.
Differences with other newer antidepressants are subtle and mostly confined to side effects. It has a similar tolerability profile to other SSRIs, with the types of adverse events usually including diarrhea, nausea, and sexual dysfunction. The incidence of diarrhea was higher with sertraline-especially when prescribed at higher doses-in comparison to other SSRIs.
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 anxiety disorder.It has also been used for premature ejaculation and vascular headaches but evidence of the effectiveness in treating those conditions is not robust.
Dosages
One reason why medical professionals find this prescription medication so appealing is due to its varying strengths and dosages. Chronic depression and the other social anxiety disorders that Sertraline HCL has been known to help come in different levels of intensity. Since Sertraline HCL can be prescribed in dosages of 25 mg to 100 mg, this offers a wider range of possibilities for the physicians use of the drug. Since every individual has a unique medical case, Sertraline HCL provides the ability to create a specialized treatment program based on the needs of the individual patient.
Potential Side Effects
With every prescribed medication, there is always the possibility of some resulting side effects. Sertraline HCL with sertraline hydrochloride has very few. Among them is the potential for nausea when the drug is first being introduced into the physical system, the possibility for sleep disturbances, such as insomnia or drowsiness, and perhaps minor diarrhea. A more common result of the sertraline hcl is the potential for increased weight gain and decrease in libido.
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