Description

Quetiapine Impurity [2-(2-Piperazin-1-Yl)Ethoxy)Ethanol] is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity in the synthesis and quality control of the atypical antipsychotic drug Quetiapine, enabling precise analytical method development and validation. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on ensuring drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific process-related impurities in Quetiapine fumarate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing, validating, and transferring robust HPLC, UPLC, or GC methods to monitor impurity levels throughout the drug manufacturing process.
• Stability Studies: Employed in forced degradation and long-term stability studies of Quetiapine to understand degradation pathways and establish appropriate shelf-life specifications.
• Regulatory Compliance & Submission: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies in accordance with ICH Q3A and Q3B guidelines.
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine batch release testing in QC laboratories to ensure Quetiapine products meet predefined purity criteria.
• Research & Development: Utilized in synthetic chemistry R&D to study reaction mechanisms, optimize synthesis pathways, and minimize the formation of this specific impurity.

Basic Information

Product Name	Quetiapine Impurity [2-(2-Piperazin-1-Yl)Ethoxy)Ethanol]
CAS No.	2206135-50-2
Molecular Formula	C10H22N2O2
Molecular Weight	202.30 g/mol
Synonyms	2-[2-(Piperazin-1-yl)ethoxy]ethanol; 1-[2-(2-Hydroxyethoxy)ethyl]piperazine; Quetiapine Related Compound; Quetiapine Fumarate Impurity; 2-(2-Piperazin-1-ylethoxy)ethanol; 2-(2-(1-Piperazinyl)ethoxy)ethanol; 1-(2-(2-Hydroxyethoxy)ethyl)piperazine
EINECS	Contact for details

Quality Control

Our Quetiapine Impurity [2-(2-Piperazin-1-Yl)Ethoxy)Ethanol] is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary reference standards where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation due to moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Meets ICH Q3C limits

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