Description

Sertraline Impurity 23 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) sertraline hydrochloride. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for maintaining the highest standards in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sertraline HCl API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or GC methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and ensure impurity levels are within specified limits.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to health authorities like the US FDA and EMA.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways, synthesis impurities, and metabolic byproducts of sertraline.

Basic Information

Item	Detail
Product Name	Sertraline Impurity 23
CAS No.	944054-29-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sertraline Related Compound 23; Sertraline EP Impurity J; Sertraline USP Impurity; (1S,4S)-4-(3,4-Dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthalenamine Impurity; Zoloft Impurity 23; Sertraline Degradation Product; Sertraline Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Sertraline Impurity 23 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH guidelines and relevant pharmacopoeial monographs. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and impurity tests conducted via validated analytical methods such as HPLC and NMR. Certificates of Analysis (COA) are available 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of atmospheric moisture, which could affect stability and purity. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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