Description

Sertraline Impurity 20 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sertraline API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor and control impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Employed to track the formation of degradation products in Sertraline under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Sertraline Impurity 20
CAS No.	1498236-91-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sertraline Related Compound 20; Sertraline EP Impurity J; Sertraline USP Impurity; Zoloft Impurity 20; (1S,4S)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine Impurity; Sertraline Process Impurity; Sertraline Degradation Product
EINECS	Contact for details

Quality Control

Our Sertraline Impurity 20 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) that detail batch-specific results, ensuring traceability and compliance with relevant guidelines such as ICH, USP, and EP. Our quality commitment supports your regulatory and research requirements with reliable and consistent reference materials.

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 product is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.