Description

Quetiapine Dimer Impurity is a critical pharmaceutical reference standard used for the identification, qualification, and quantification of a key dimeric degradation product in Quetiapine formulations. This high-purity impurity standard is essential for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) and its final drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for rigorous quality control, method validation, and stability studies.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the precise analysis of Quetiapine fumarate and related drug substances.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing and validating chromatographic methods to separate and quantify the dimer impurity.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of degradation products in Quetiapine under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity profiles.
• Research and Development (R&D): Used in pharmaceutical R&D to understand degradation pathways and improve formulation stability.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial standards (e.g., USP, EP) for impurity limits.

Basic Information

Product Name	Quetiapine Dimer Impurity
CAS No.	945668-94-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Quetiapine Dimer; Quetiapine Dimer Related Compound; Quetiapine Fumarate Dimer Impurity; 11-[4-[2-(2-Hydroxyethoxy)ethyl]-1-piperazinyl]dibenzo[b,f][1,4]thiazepine Dimer; Dibenzo[b,f][1,4]thiazepine Dimer Derivative; Quetiapine Degradation Product; Seroquel Dimer Impurity
EINECS	Contact for details

Quality Control

Every batch of our Quetiapine Dimer Impurity is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by advanced spectroscopic and chromatographic techniques. A detailed Certificate of Analysis (COA) is supplied with each product, confirming identity, purity, and impurity profile. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area.

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)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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