Description

Quetiapine-D8 Hemifumarate is a deuterated internal standard of the atypical antipsychotic quetiapine, specifically labeled with eight deuterium atoms. This high-purity reference material is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, such as LC-MS/MS, in pharmacokinetic and metabolism studies. It is a critical tool for pharmaceutical R&D laboratories, clinical research organizations, and regulatory bodies requiring precise drug level monitoring and method validation.

Application

• Bioanalytical Reference Standard: Primary use as an internal standard for the accurate quantification of quetiapine in biological matrices (plasma, serum, urine) via mass spectrometry.
• Pharmacokinetic & Metabolism Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Method Development & Validation: Serves as a critical component in developing, optimizing, and validating robust LC-MS/MS and GC-MS analytical methods for regulatory compliance.
• Forensic & Clinical Toxicology: Used in assays for therapeutic drug monitoring (TDM) and in forensic investigations to determine quetiapine concentrations.
• Pharmaceutical Quality Control: Supports impurity profiling and stability-indicating assays for quetiapine active pharmaceutical ingredient (API) and finished dosage forms.

Basic Information

Product Name	Quetiapine-D8 Hemifumarate
CAS No.	1185247-12-4
Molecular Formula	C21H17D8N3O2S • 0.5C4H4O4
Molecular Weight	~434.6 g/mol
Synonyms	Quetiapine-d8 Hemifumarate; 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl-d8)ethoxy]ethanol Hemifumarate; Seroquel-d8 Hemifumarate; ICI 204,636-d8 Hemifumarate; Quetiapine (D8) Hemifumarate; Deuterated Quetiapine Hemifumarate; Quetiapine-d8 (Hemifumarate Salt); 11-[4-[2-(2-Hydroxyethoxy-d4)ethyl-d4]piperazin-1-yl]dibenzo[b,f][1,4]thiazepine Hemifumarate
EINECS	Contact for details

Quality Control

Our Quetiapine-D8 Hemifumarate is manufactured under strict quality systems to ensure the highest standards of isotopic purity and chemical integrity. Each batch is comprehensively characterized and tested, with specifications typically meeting or exceeding ≥98% chemical purity and ≥99% isotopic enrichment (D8) as determined by advanced analytical techniques. A comprehensive Certificate of Analysis (COA) detailing NMR, HPLC, and MS data is provided with every shipment.

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 must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D8, MS)	≥99.0 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.