Description

Quetiapine Impurity CAS NO 2206135-48-8 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of process-related impurities during the manufacturing of the antipsychotic drug Quetiapine. It is primarily needed by analytical laboratories, quality control departments, and regulatory affairs teams within the global pharmaceutical and fine chemical industries to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Quetiapine Fumarate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity specifications and justify safety thresholds.
• Stability Studies: Used to track the formation of degradation products in stability testing of Quetiapine under various stress conditions.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Item	Detail
Product Name	Quetiapine Impurity
CAS No.	2206135-48-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Quetiapine Related Compound; Quetiapine Fumarate Impurity; Quetiapine Process Impurity; Quetiapine Specified Impurity; Quetiapine Degradation Product; 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol Impurity; Seroquel Impurity
EINECS	Contact for details

Quality Control

Every batch of Quetiapine Impurity (CAS 2206135-48-8) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, MS, NMR) to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. The container should be kept tightly sealed in a desiccator after opening.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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