Description

Quetiapine Ep Impurity W 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 (API) Quetiapine. 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 the production of this important antipsychotic medication.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Quetiapine-related impurities in accordance with ICH guidelines.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing of Quetiapine API and finished dosage forms to monitor impurity levels and ensure product consistency.
• Regulatory Compliance & Submission: Essential for generating impurity data required for regulatory filings (e.g., with FDA, EMA) and for stability studies.
• Research & Development (R&D): Used in studies to understand the formation, fate, and degradation pathways of impurities during synthesis and storage.
• Pharmacopoeial Testing: Applied as a system suitability standard in testing procedures aligned with pharmacopoeial monographs (e.g., USP, EP, BP).

Basic Information

Item	Details
Product Name	Quetiapine Ep Impurity W
CAS No.	1800608-95-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Quetiapine Impurity W; Quetiapine Related Compound W; Quetiapine EP Impurity W; 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol Impurity; Quetiapine Fumarate Impurity W; Seroquel Impurity W; ICI 204,636 Impurity W
EINECS	Contact for details

Quality Control

Our Quetiapine Ep Impurity W is manufactured under strict quality systems to meet the exacting standards of pharmaceutical analysis. Each batch undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results against established specifications. Our quality commitment ensures the material's suitability for its intended use as a reference standard in regulated environments.

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 tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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