Description

Sertraline Ep Impurity B CAS NO 52758-05-1 is a high-purity chemical reference standard, specifically identified as a known impurity of the active pharmaceutical ingredient Sertraline. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of impurities during drug manufacturing. It is an essential material for analytical chemists, quality assurance professionals, and regulatory affairs specialists in the pharmaceutical and contract research organization (CRO) sectors to ensure product safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify Sertraline Ep Impurity B in Sertraline hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC analytical methods for impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to ensure API and drug products meet pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B) for related substances.
• Stability Studies and Forced Degradation Testing: Acts as a marker to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity understanding and control strategies.
• Research and Development: Utilized in synthetic chemistry R&D to study impurity formation pathways and develop purification processes to minimize its presence.

Basic Information

Product Name	Sertraline Ep Impurity B
CAS No.	52758-05-1
Molecular Formula	C17H17Cl2N
Molecular Weight	314.23 g/mol
Synonyms	(1S,4S)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine; Sertraline Impurity B (EP); Sertraline Related Compound B; 1-Naphthalenamine, 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-, (1S,4S)-; Sertraline EP Impurity B; Sertraline Impurity 2; Zoloft Impurity B
EINECS	Contact for details

Quality Control

Our Sertraline Ep Impurity B is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is light-sensitive (store away from light).

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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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