Description

Gefitinib-D6 is a deuterated isotopologue of the well-known epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, Gefitinib. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolism studies. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in the development and analysis of targeted cancer therapies.

Application

• Bioanalytical Internal Standard: Primary use as a deuterated internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of Gefitinib in biological matrices like plasma, serum, and tissue homogenates.
• Pharmacokinetic (PK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Drug Metabolism Studies: Facilitates the identification and quantification of Gefitinib metabolites, aiding in the understanding of metabolic pathways and potential drug-drug interactions.
• Method Development & Validation: Serves as a critical reference material for developing, optimizing, and validating robust analytical methods compliant with GLP and FDA/EMA guidelines.
• Quality Control in Manufacturing: Can be utilized in impurity profiling and stability-indicating assay methods for the parent drug substance.

Basic Information

Product Name	Gefitinib-D6
CAS No.	1228664-49-0
Molecular Formula	C22H18D6ClFN4O3
Molecular Weight	446.92 g/mol
Synonyms	N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-[3-(morpholin-4-yl)propoxy]quinazolin-4-amine-d6; ZD1839-d6; Iressa-d6; Gefitinib (hexadeuterated); Gefitinib-d6 (labeled at morpholine ring); 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-, labeled with deuterium
EINECS	Contact for details

Quality Control

Our Gefitinib-D6 is manufactured under strict quality control protocols to ensure exceptional isotopic purity and chemical integrity, meeting the stringent requirements for analytical reference standards. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for isotopic enrichment (D-content), chemical purity (by HPLC), and identity confirmation (by NMR and MS). We support research compliant with GLP and relevant regulatory frameworks.

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). Keep the container tightly sealed in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (D-content)	≥98.0 atom % D
Chemical Purity (by NMR)	Conforms
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%

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