Description

Quetiapine Ep Impurity V 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 V in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Critical for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) protocols, in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure they remain within specified safety thresholds as per pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation and growth of this impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Facilitates studies on impurity formation pathways, degradation chemistry, and process optimization during Quetiapine synthesis.

Basic Information

Product Name	Quetiapine Ep Impurity V
CAS No.	2204369-14-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Quetiapine EP Impurity V; Quetiapine Related Compound V; Quetiapine Impurity V; 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol Impurity; 11-Piperazinyldibenzo[b,f][1,4]thiazepine Impurity V; Quetiapine Fumarate Impurity V; Seroquel Impurity V
EINECS	Contact for details

Quality Control

Our Quetiapine Ep Impurity V is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

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 degradation. For long-term storage, consider desiccants or inert atmosphere.

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.