Description

Quetiapine Impurity T (Quetiapine Morpholine Impurity) CAS NO 5747-46-6 is a critical pharmaceutical reference standard used for the identification and quantification of a specific process-related impurity in the active pharmaceutical ingredient (API) Quetiapine. This compound is essential for ensuring the purity, safety, and efficacy of Quetiapine formulations during development and manufacturing. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for quality control, method validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify Quetiapine Morpholine Impurity in Quetiapine fumarate API and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating stability-indicating chromatographic methods for Quetiapine.
• Quality Control and Batch Release Testing: Enables precise impurity monitoring to ensure API and drug product batches meet ICH Q3A(R2) and pharmacopeial (USP, EP) guidelines for impurities.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions and Compliance: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research and Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Quetiapine Impurity T (Quetiapine Morpholine Impurity)
CAS No.	5747-46-6
Molecular Formula	C21H25N3O2S
Molecular Weight	383.51 g/mol
Synonyms	Quetiapine Morpholine Impurity; Quetiapine Related Compound T; 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol; 11-[4-[2-(2-Hydroxyethoxy)ethyl]piperazin-1-yl]dibenzo[b,f][1,4]thiazepine; Quetiapine EP Impurity T; Quetiapine USP Related Compound T; Quetiapine Hydroxyethyl Impurity; DBZ HEE
EINECS	Contact for details

Quality Control

Our Quetiapine Impurity T is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with current industry standards for pharmaceutical reference materials. Specifications are aligned with the requirements of major pharmacopeias.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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