Description

Quetiapine Ep Impurity C is a high-purity reference standard used in the pharmaceutical development and quality control of the antipsychotic drug Quetiapine. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of this specific impurity. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for method development, validation, and routine quality control testing of Quetiapine Fumarate active pharmaceutical ingredient (API) and finished dosage forms.
• Impurity Profiling and Identification: Used in HPLC, UPLC, and LC-MS analyses to identify and quantify Quetiapine Ep Impurity C during stability studies and batch release testing to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Research and Development: Employed in synthetic route optimization and degradation studies to understand the formation pathways and control strategies for this impurity.
• Calibration and System Suitability: Serves as a critical component for calibrating analytical instruments and establishing system suitability parameters in compendial (e.g., USP, EP) testing methods.

Basic Information

Product Name	Quetiapine Ep Impurity C
CAS No.	1798840-31-9
Molecular Formula	C21H25N3O2S
Molecular Weight	383.51 g/mol
Synonyms	Quetiapine EP Impurity C; Quetiapine Related Compound C; 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol; 11-Piperazinyldibenzo[b,f][1,4]thiazepine-2-ethoxyethanol; Quetiapine N-Oxide Impurity; DBZ N-Oxide Ethanol Metabolite; Quetiapine Metabolite (N-Oxide Ethanol)
EINECS	Contact for details

Quality Control

Every batch of Quetiapine Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container kept sealed to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown 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.