Description

Quetiapine Impurity E is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Quetiapine. This compound is critical for ensuring the purity, safety, and efficacy of Quetiapine formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Quetiapine Impurity E in drug substance and drug product testing.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Quetiapine fumarate API.
• Quality Control & Assurance: Serves as a system suitability standard and a calibrant in routine quality control laboratories to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Quetiapine.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and impurity profile of Quetiapine during synthesis and formulation processes.

Basic Information

Product Name	Quetiapine Impurity E
CAS No.	1371638-05-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Quetiapine Related Compound E; 11-(Piperazin-1-yl)dibenzo[b,f][1,4]thiazepine Impurity E; DBZ-Thiazepine Impurity E; Quetiapine Fumarate Impurity E; 2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethanol Impurity; IUPAC Name: Contact for details
EINECS	Contact for details

Quality Control

Our Quetiapine Impurity E is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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