Description

Quetiapine Impurity 8 CAS NO 1977-09-9 is a designated impurity standard used in the analytical profiling and quality control of the antipsychotic drug Quetiapine. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure drug purity, safety, and regulatory compliance. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) for method validation and impurity identification.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Quetiapine Impurity 8 in active pharmaceutical ingredient (API) and finished drug product testing.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) or other chromatographic methods used in impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions (e.g., heat, humidity, light) as part of drug stability testing protocols.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies for Quetiapine.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for Quetiapine.

Basic Information

Product Name	Quetiapine Impurity 8
CAS No.	1977-09-9
Molecular Formula	C21H25N3O2S
Molecular Weight	383.51 g/mol
Synonyms	Quetiapine Related Compound H; 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol; 11-[4-[2-(2-Hydroxyethoxy)ethyl]-1-piperazinyl]dibenzo[b,f][1,4]thiazepine; Quetiapine EP Impurity H; Quetiapine USP Related Compound H; Quetiapine Hydroxyethyl Impurity; DBZ HPE Impurity
EINECS	Contact for details

Quality Control

Every batch of Quetiapine Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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