Description

Quetiapine Hydroxy Impurity is a key pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) quetiapine fumarate, an atypical antipsychotic. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in drug development and regulatory compliance. The use of this well-characterized impurity standard is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of process-related impurities in Quetiapine Fumarate API.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in QC laboratories.
• Stability Indicating Studies: Employed to monitor the formation of degradation products in quetiapine formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) to demonstrate control over impurity levels as per ICH Q3A and Q3B guidelines.
• Pharmacopeial Testing: Used for testing against specifications outlined in the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or other pharmacopeias.
• Research & Development: Aids in synthetic route optimization and process chemistry studies to minimize the formation of this impurity.
• Quality Control & Batch Release: Acts as a system suitability standard and for routine quality control testing of quetiapine API and finished dosage forms.

Basic Information

Product Name	Quetiapine Hydroxy Impurity
CAS No.	329216-67-3
Molecular Formula	C21H25N3O2S
Molecular Weight	383.51 g/mol
Synonyms	11-Hydroxy Quetiapine; Quetiapine Hydroxy Metabolite; 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol; 11-Hydroxyquetiapine; Quetiapine Related Compound H; Quetiapine Impurity H; Quetiapine EP Impurity H; Quetiapine USP Related Compound H
EINECS	Contact for details

Quality Control

Our Quetiapine Hydroxy Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and tested using validated methods, including HPLC, NMR, and Mass Spectrometry, to confirm identity, purity, and strength. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against relevant pharmacopeial (USP/EP) and in-house specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unspecified impurity ≤ 0.5% Total impurities ≤ 2.0%

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