Description

(1R,4R)-Sertraline 4-Chlorophenyl Impurity Hcl is a high-purity chemical reference standard, specifically the hydrochloride salt of a key stereoisomeric impurity related to the antidepressant drug Sertraline. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, validation, and quality control to ensure drug safety and efficacy. It is primarily used by analytical chemists, quality assurance laboratories, and R&D departments within the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) for the identification and quantification of the (1R,4R)-stereoisomer impurity in Sertraline Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to separate and analyze Sertraline-related substances.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to monitor impurity levels and ensure compliance with strict pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed in forced degradation and long-term stability studies of Sertraline to understand degradation pathways and impurity formation over time.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies for Sertraline-based drug products.
• Research on Stereochemistry and Chirality: Used in academic and industrial research focused on the impact of stereoisomers on pharmacological activity, metabolism, and toxicity.

Basic Information

Product Name	(1R,4R)-Sertraline 4-Chlorophenyl Impurity Hcl
CAS No.	79617-90-6
Molecular Formula	C17H17Cl3N•HCl
Molecular Weight	394.70 g/mol
Synonyms	(1R,4R)-1-Naphthalenamine, 4-(3,4-dichlorophenyl)-3,4-dihydro-1(2H)-naphthalenamine, Hydrochloride; (1R,4R)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine Hydrochloride Impurity; (1R-cis)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine HCl Impurity; Sertraline Impurity H ((1R,4R)-Isomer) Hydrochloride; Sertraline Related Compound H HCl; Zoloft Impurity H HCl; (1R,4R)-Sertraline Impurity Hydrochloride
EINECS	Contact for details

Quality Control

Our (1R,4R)-Sertraline 4-Chlorophenyl Impurity Hcl is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for assay, chiral purity, related substances, residual solvents, and other critical parameters. We adhere to relevant ICH guidelines and can support compliance with pharmacopeial standards (USP, EP) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0% (1R,4R)-isomer
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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