Sertraline Hydrochloride API, commonly known as Sertraline HCl, is the hydrochloride salt of sertraline and belongs to the selective serotonin reuptake inhibitor (SSRI) class of pharmaceutical compounds. Sertraline Hydrochloride is chemically identified as (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalen-1-amine hydrochloride.
Sertraline Hydrochloride has the molecular formula C₁₇H₁₇Cl₂N·HCl, commonly represented as C₁₇H₁₈Cl₃N, and a molecular weight of 342.69 g/mol. Its primary CAS Number is 79559-97-0 and its FDA GSRS UNII is UTI8907Y6X.
Swapnroop Drugs and Pharmaceuticals provides Sertraline HCl API for pharmaceutical manufacturing and development requirements, with emphasis on chemical identity, pharmacopoeial quality, analytical testing and technical documentation.
Sertraline Hydrochloride is the hydrochloride salt of the active pharmaceutical ingredient sertraline. It is an SSRI that increases serotonergic activity in the central nervous system by inhibiting neuronal reuptake of serotonin (5-HT). Current FDA labeling identifies sertraline hydrochloride as an SSRI.
Sertraline Hydrochloride is used in pharmaceutical formulations for several approved indications, including major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, social anxiety disorder and premenstrual dysphoric disorder, depending on the applicable product labeling.
| Parameter | Value |
|---|---|
| Product Name | Sertraline Hydrochloride |
| Common Name | Sertraline HCl / Sertraline HCL |
| API Type | Small-Molecule API |
| CAS Number | 79559-97-0 |
| Molecular Formula | C₁₇H₁₇Cl₂N·HCl |
| Molecular Formula, condensed | C₁₇H₁₈Cl₃N |
| Molecular Weight | 342.69 g/mol |
| FDA UNII | UTI8907Y6X |
| Chemical Class | Naphthalenamine derivative |
| Pharmacological Class | Selective Serotonin Reuptake Inhibitor |
| Defined Stereocenters | 2 |
| Physical Form | White to off-white crystalline powder |
| Primary Therapeutic Area | CNS / Psychiatry |
The chemical identity and molecular data are supported by FDA GSRS, FDA chemistry documentation and PubChem.
Sertraline Hydrochloride contains a substituted tetralin/naphthalenamine structure with a 3,4-dichlorophenyl group and methylamino functionality. The hydrochloride salt improves the pharmaceutical handling characteristics of the active compound.
FDA describes Sertraline Hydrochloride as a white or off-white crystalline powder. It is slightly soluble in water and isopropanol, sparingly or slightly soluble in absolute alcohol, and slightly to very slightly soluble in acetone.
Sertraline Hydrochloride is an established pharmaceutical API used in oral dosage-form development.
FDA labeling identifies sertraline hydrochloride as an SSRI and describes its mechanism as inhibition of neuronal serotonin reuptake.
Depending on the approved formulation and jurisdiction, pharmaceutical applications include:
Sertraline increases serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT). This pharmacological activity forms the basis for its classification as a selective serotonin reuptake inhibitor.
Sertraline Hydrochloride is particularly suitable for a specification-driven CMS page because USP provides a monograph for the API.
The current USP-NF listing defines Sertraline Hydrochloride as containing NLT 97.0% and NMT 102.0% of sertraline hydrochloride, calculated on the anhydrous basis.
USP-related analytical controls include assay, organic impurities, water determination and other quality tests. The USP material reports NMT 0.50% water, while the monograph's impurity table specifies individual impurity limits and total impurities NMT 0.5%.
Typical quality-control testing includes:
Swapnroop Drugs and Pharmaceuticals provides Sertraline Hydrochloride API for pharmaceutical development and manufacturing requirements.
Sertraline HCl quality management should include controlled raw materials, process controls, validated analytical methods, impurity monitoring and appropriate documentation.
Product documentation may include:
Sertraline Hydrochloride should be preserved in tight, light-resistant containers. The USP monograph specifies storage at a temperature not exceeding 40°C.
For commercial API handling, actual storage conditions should also follow the manufacturer's validated stability data and approved specification.
Typical documentation may include:
Swapnroop Drugs and Pharmaceuticals focuses on pharmaceutical API solutions with emphasis on accurate chemical identity, pharmacopoeial quality, analytical testing and documentation.
Key advantages include:
For Sertraline Hydrochloride API requirements, contact Swapnroop Drugs and Pharmaceuticals for product specifications, documentation, availability and commercial information.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Residue on Ignition | NMT 0.3% |
| Heavy Metals | NMT 30 ppm |
| Total Impurities | NMT 0.5% |
| Water Content | NMT 0.5% |