Description

Quetiapine Ep Impurity N is a high-purity reference standard used in the analytical profiling and quality control of the antipsychotic drug Quetiapine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is an essential material for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Quetiapine Ep Impurity N in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing within QC laboratories to monitor impurity levels and ensure they remain within specified safety thresholds.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light) to establish shelf-life and storage recommendations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity control.
• Research on Degradation Pathways: Serves as a tool for researchers studying the degradation mechanisms and stability profile of Quetiapine fumarate.

Basic Information

Product Name	Quetiapine Ep Impurity N
CAS No.	1800291-86-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Quetiapine EP Impurity N; Quetiapine Related Compound N; 11-(4-(2-(2-Hydroxyethoxy)ethyl)piperazin-1-yl)dibenzo[b,f][1,4]thiazepine; Dibenzo[b,f][1,4]thiazepine, 11-[4-[2-(2-hydroxyethoxy)ethyl]-1-piperazinyl]-; Quetiapine Hydroxyethyl Impurity; Quetiapine Metabolite Impurity
EINECS	Contact for details

Quality Control

Every batch of Quetiapine Ep Impurity N is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters.

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 must be kept tightly sealed in a dry environment to prevent moisture absorption, which may affect stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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