Description

Sertraline Dimethyl Impurity Hcl is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control of Sertraline hydrochloride, an essential active pharmaceutical ingredient (API) for antidepressant medications. It is primarily required by analytical laboratories, quality assurance departments, and API manufacturers for method validation, stability studies, and regulatory compliance testing to ensure drug safety and efficacy.

Application

• Pharmaceutical Impurity Standard: Used as a certified reference material (CRM) for the identification and quantification of the dimethyl impurity in Sertraline hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC testing of Sertraline batches to ensure impurity levels remain within specified safety thresholds.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (heat, light, humidity) during drug shelf-life studies.
• Regulatory Submissions: Critical for preparing impurity profiles and supporting documentation for regulatory filings with agencies like the US FDA, EMA, and others.
• Pharmacopoeial Testing: Supports testing to meet the monograph specifications of USP, EP, BP, and other pharmacopoeias for Sertraline hydrochloride.

Basic Information

Item	Detail
Product Name	Sertraline Dimethyl Impurity Hcl
CAS No.	122873-20-5
Molecular Formula	C19H21Cl2N
Molecular Weight	350.29 g/mol
Synonyms	(1S,4S)-4-(3,4-Dichlorophenyl)-N,N-dimethyl-1,2,3,4-tetrahydro-1-naphthalenamine hydrochloride; Sertraline Dimethylamine Impurity Hydrochloride; Sertraline N,N-Dimethyl Impurity HCl; Sertraline Related Compound H; Zoloft Dimethyl Impurity HCl; Sertraline Dimethyl Analog HCl; Sertraline Process Impurity HCl
EINECS	Contact for details

Quality Control

Every batch of Sertraline Dimethyl Impurity Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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