Description

Sertraline Hydrochloride CAS NO 79559-97-0 is the hydrochloride salt of sertraline, a selective serotonin reuptake inhibitor (SSRI). This active pharmaceutical ingredient (API) is a critical component in the formulation of antidepressant and anti-anxiety medications, valued for its high purity and consistent efficacy. It is essential for pharmaceutical manufacturers, research institutions, and compounding facilities engaged in the development and production of central nervous system (CNS) therapeutics.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of antidepressant tablets, capsules, and oral solutions.
• Generic Drug Formulation: Used in the production of generic versions of sertraline-based medications following patent expiry.
• Clinical Research: Serves as a reference standard and raw material in preclinical and clinical studies for new CNS drug development.
• Compounding Pharmacy: Utilized in specialized pharmacy compounding for customized patient dosage forms.
• Analytical Testing: Acts as a high-purity standard for quality control and assay validation in analytical laboratories.
• Bulk Pharmaceutical Intermediates: Key intermediate for further chemical synthesis in advanced pharmaceutical production.

Basic Information

Product Name	Sertraline Hydrochloride
CAS No.	79559-97-0
Molecular Formula	C17H17Cl2N•HCl
Molecular Weight	342.69 g/mol
Synonyms	(1S,4S)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride; Zoloft Hydrochloride; Lustral Hydrochloride; CP-51974-01; (+)-Sertraline Hydrochloride; (1S-cis)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride
EINECS	Contact for details

Quality Control

Our Sertraline Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with pharmacopeial standards such as USP and EP. A Certificate of Analysis (COA) documenting all test results is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Conforms to standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Optical Rotation	Specific range provided on COA

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.