Description

Quetiapine Ep Impurity J CAS NO 1356906-17-6 is a designated impurity standard used in the pharmaceutical development and quality control of the antipsychotic drug Quetiapine. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, process validation, and compliance testing for Quetiapine formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Quetiapine-related impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Quetiapine products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Acts as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Used to study and optimize synthesis pathways to minimize the formation of this specific impurity during Quetiapine manufacturing.

Basic Information

Product Name	Quetiapine Ep Impurity J
CAS No.	1356906-17-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Quetiapine Impurity J; Quetiapine Related Compound J; 11-(4-(2-(2-Hydroxyethoxy)ethyl)piperazin-1-yl)dibenzo[b,f][1,4]thiazepine; Quetiapine EP Impurity J; Quetiapine USP Impurity J; Dibenzo[b,f][1,4]thiazepine, 11-[4-[2-(2-hydroxyethoxy)ethyl]-1-piperazinyl]-; Quetiapine Process Impurity J
EINECS	Contact for details

Quality Control

Every batch of Quetiapine Ep Impurity J is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including chromatographic purity and spectroscopic identification, to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay.

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 must be kept in a desiccated environment to maintain stability and purity. The container should be opened only under controlled, low-humidity conditions.

Specification

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

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