Description

Quetiapine Impurity 1 is a designated impurity standard used in the analytical profiling and quality control of the antipsychotic drug Quetiapine. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final pharmaceutical product by serving as a reference marker for impurity identification and quantification. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments focused on method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Quetiapine Impurity 1 in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities during drug development and manufacturing.
• Quality Control & Batch Release: Used in routine QA/QC testing to ensure Quetiapine API and drug products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed as an analytical standard to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies for Quetiapine.
• Research on Degradation Pathways: Serves as a tool in pharmaceutical R&D to study the degradation mechanisms and kinetics of Quetiapine.

Basic Information

Product Name	Quetiapine Impurity 1
CAS No.	3985-12-4
Molecular Formula	C21H25N3O2S
Molecular Weight	383.51 g/mol
Synonyms	11-(Piperazin-1-yl)dibenzo[b,f][1,4]thiazepine; Quetiapine Related Compound A; Quetiapine EP Impurity A; Quetiapine USP Impurity A; DBZP; 2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethanol Impurity; Quetiapine Deshydroxyethyl Impurity
EINECS	Contact for details

Quality Control

Our Quetiapine Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis to ensure it meets the high standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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)	≤ 0.5%

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