Description

Quetiapine-D4 Fumarate is a high-purity, deuterium-labeled internal standard critical for modern analytical chemistry. This stable isotope-labeled compound is essential for ensuring the accuracy, precision, and reliability of quantitative mass spectrometry analyses. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities engaged in bioanalytical method development, pharmacokinetic studies, and drug metabolism research.

Application

• Quantitative Bioanalysis: Serves as an internal standard for the precise quantification of Quetiapine and its metabolites in biological matrices (plasma, serum, urine) using LC-MS/MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug concentration over time to determine absorption, distribution, metabolism, and excretion (ADME) profiles.
• Drug Metabolism Research: Used in metabolite identification and profiling studies to understand the biotransformation pathways of Quetiapine.
• Clinical Trial Support: Critical for generating reliable analytical data in clinical studies to meet stringent regulatory submission requirements (FDA, EMA).
• Forensic Toxicology: Supports accurate measurement of Quetiapine levels in forensic investigations and therapeutic drug monitoring (TDM).
• Method Development and Validation: A key reagent for developing, optimizing, and validating robust, GLP-compliant analytical methods.
• Quality Control in Manufacturing: Can be utilized in impurity profiling and stability-indicating methods for active pharmaceutical ingredient (API) quality assurance.

Basic Information

Product Name	Quetiapine-D4 Fumarate
CAS No.	1287376-15-1
Molecular Formula	C21H21D4N3O2S • C4H4O4
Molecular Weight	Contact for details
Synonyms	2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol-D4 Fumarate; Quetiapine (tetradeutero) Fumarate; Quetiapine-d4 Hemifumarate; 11-[4-[2-(2-Hydroxyethoxy)ethyl]-1-piperazinyl]dibenzo[b,f][1,4]thiazepine-d4 Fumarate; Seroquel-D4 Fumarate; Deuterated Quetiapine Fumarate Internal Standard
EINECS	Contact for details

Quality Control

Our Quetiapine-D4 Fumarate is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic enrichment (e.g., D4 ≥ 98%), chemical purity (by HPLC), and confirmation of structure. We adhere to relevant industry standards for reference materials, and our quality commitment supports compliance with GLP and GMP guidelines where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC/MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D4)	≥ 98 atom % D
Chemical Purity (by HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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