Description

Sertraline Ep Impurity G is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Sertraline. This compound serves as a key marker for identifying and quantifying a specific enantiomeric impurity during the manufacturing and regulatory testing of Sertraline hydrochloride, ensuring the final drug product meets stringent pharmacopeial purity requirements. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams focused on analytical method development, validation, and compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Sertraline-related impurities in compliance with ICH Q3A, Q3B, USP, and EP guidelines.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods for Sertraline API and finished dosage forms.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels in commercial Sertraline API batches, ensuring they remain within specified limits.
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity formation in Sertraline formulations under various stress conditions.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., Drug Master Files, CMC sections) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research on Synthesis Pathways: Used by process chemists to study and optimize synthetic routes to minimize the formation of this specific enantiomeric impurity.

Basic Information

Product Name	Sertraline Ep Impurity G
CAS No.	79645-15-1
Molecular Formula	C17H17Cl2N
Molecular Weight	306.23 g/mol
Synonyms	(1S,4S)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine; (1S,4S)-Sertraline; Sertraline Enantiomer; Sertraline EP Impurity G; Sertraline Related Compound G; (1S-cis)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine; Lustral Impurity G; Zoloft Impurity G
EINECS	Contact for details

Quality Control

Every batch of Sertraline Ep Impurity G is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of pharmaceutical reference material production. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, chiral purity, residual solvents, and identity confirmation (IR, MS). We support compliance with ICH, USP, and EP guidelines.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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