Description

Quetiapine-D8 Hemifumarate is a deuterium-labeled analog of the atypical antipsychotic quetiapine, specifically designed for use as an internal standard in analytical chemistry. This high-purity reference material is critical for ensuring the accuracy and reliability of quantitative bioanalytical methods, such as LC-MS/MS, in pharmacokinetic and metabolism studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory bodies requiring precise drug quantification.

Application

• Internal Standard for LC-MS/MS Analysis: Primary application for accurate quantification of quetiapine in biological matrices (plasma, serum, urine).
• Pharmacokinetic and Bioequivalence Studies: Enables precise measurement of drug concentration over time to assess ADME (Absorption, Distribution, Metabolism, Excretion) profiles.
• Forensic and Clinical Toxicology: Used in method development and validation for the detection and quantification of quetiapine in forensic and clinical samples.
• Drug Metabolism Research: Facilitates studies on the metabolic pathways and stability of quetiapine.
• Pharmaceutical Quality Control: Supports analytical method development for impurity profiling and assay of quetiapine in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Regulatory Submissions: Provides the traceable and stable standard required for GLP/GMP-compliant analytical data submitted to agencies like the FDA and EMA.

Basic Information

Product Name	Quetiapine-D8 Hemifumarate
CAS No.	1435938-24-1
Molecular Formula	C21H17D8N3O2S • 0.5C4H4O4
Molecular Weight	~429.55 g/mol
Synonyms	2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol-D8 Hemifumarate; Quetiapine-d8 Fumarate (1:0.5); Seroquel-d8 Hemifumarate; 11-[4-[2-(2-Hydroxyethoxy)ethyl]-1-piperazinyl]dibenzo[b,f][1,4]thiazepine-d8 Hemifumarate; Quetiapine (D8) Hemifumarate; Deuterated Quetiapine Hemifumarate
EINECS	Contact for details

Quality Control

Our Quetiapine-D8 Hemifumarate is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical integrity. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced spectroscopic and chromatographic tests, including NMR (for deuterium incorporation) and HPLC. We support GLP/GMP-compliant research and can provide stability data and method validation support upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. This compound is hygroscopic (moisture-sensitive); desiccants are recommended for long-term storage.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0% (Chemical Purity)
Isotopic Purity (NMR/LC-MS)	≥ 98.0 atom % D
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.