Description

Gefitinib D8 is a deuterated isotopologue of the well-known tyrosine kinase inhibitor Gefitinib, where eight hydrogen atoms are replaced with deuterium. This stable isotope-labeled compound is a critical tool for quantitative bioanalytical research, offering enhanced mass spectrometry signal detection and improved metabolic stability studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in advanced pharmacokinetic, pharmacodynamic, and metabolite profiling studies for oncology drug development.

Application

• Internal Standard for LC-MS/MS: Serves as a high-purity, non-interfering internal standard for the precise quantification of Gefitinib in complex biological matrices like plasma, serum, and tissue homogenates.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in absorption, distribution, metabolism, and excretion (ADME) studies to track the parent drug and elucidate metabolic pathways with greater accuracy.
• Biomedical Research: Enables sensitive and specific assay development for monitoring Gefitinib concentrations in preclinical and clinical research settings.
• Stable Isotope Tracing: Facilitates mechanistic studies of EGFR (Epidermal Growth Factor Receptor) inhibition and resistance mechanisms in cancer cell lines and model organisms.
• Quality Control & Method Validation: Essential for validating bioanalytical methods according to FDA, EMA, and ICH guidelines, ensuring reliability and reproducibility of data.

Basic Information

Product Name	Gefitinib D8
CAS No.	857091-32-8
Molecular Formula	C₂₂H₁₆D₈ClFN₄O₃
Molecular Weight	446.94 g/mol
Synonyms	Gefitinib-d8; N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-[3-(morpholin-4-yl)propoxy]quinazolin-4-amine-d8; ZD1839-d8; Iressa-d8; 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-, Labeled with Deuterium; Gefitinib (Deuterated); Gefitinib Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Gefitinib D8 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to ensure the product meets the high standards required for sensitive bioanalytical applications. A detailed Certificate of Analysis (COA) is supplied with each shipment, reporting critical parameters such as isotopic purity, chemical purity, and the absence of interfering impurities. Our quality commitment aligns with the needs of GLP/GMP-compliant research environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC/MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (Deuterium Content)	≥98.0 atom % D
Chemical Purity (by HPLC)	≥95.0%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.5%

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