Description

Agomelatine Impurity 1 CAS NO 1352139-51-5 is a high-purity 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 Agomelatine. 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 development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Agomelatine Impurity 1 in drug substances and products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Agomelatine API and formulations.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Agomelatine meets pharmacopeial specifications (e.g., ICH Q3A/B) for impurity limits.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Agomelatine.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process optimization for Agomelatine.

Basic Information

Product Name	Agomelatine Impurity 1
CAS No.	1352139-51-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Agomelatine Related Compound 1; Agomelatine Impurity A; N-[2-(7-Methoxy-1-naphthyl)ethyl]acetamide Impurity; Agomelatine EP Impurity A; Agomelatine USP Impurity; S 20098 Impurity 1; S20098 Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Agomelatine Impurity 1 is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure compliance with high-grade reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is 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 nature, the container should be kept in a desiccated environment to prevent moisture absorption. Keep away from incompatible materials.

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)	≤ 1.0%

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