Description

Gefitinib o-Methyl-D3 is a deuterated isotopologue of the active pharmaceutical ingredient Gefitinib, specifically labeled on the o-methyl group. This compound is a critical reference standard and intermediate used in the development and validation of bioanalytical methods for pharmacokinetic and metabolic studies. It is essential for researchers and manufacturers in the pharmaceutical and biotechnology sectors who require high-purity, stable isotopically labeled materials for mass spectrometry-based assays, ensuring accurate quantification and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified internal standard for the precise quantification of Gefitinib and its metabolites in biological matrices using LC-MS/MS.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used in tracer studies to elucidate metabolic pathways, absorption, distribution, and excretion profiles of Gefitinib.
• Analytical Method Development: Critical for developing and validating robust, sensitive, and specific HPLC and mass spectrometry methods in compliance with GLP and ICH guidelines.
• Clinical Research: Employed in clinical trials to monitor drug levels in patients, supporting personalized medicine approaches for oncology treatments.
• Impurity Profiling: Acts as a marker in stability studies and impurity identification protocols for Gefitinib drug substance and product manufacturing.
• Isotope Dilution Mass Spectrometry (IDMS): Provides the high-purity labeled compound required for this gold-standard quantitative technique.

Basic Information

Item	Detail
Product Name	Gefitinib o-Methyl-D3
CAS No.	1173976-40-3
Molecular Formula	C22H21D3ClFN4O3
Molecular Weight	446.91 g/mol
Synonyms	Gefitinib-d3 (o-methyl); N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-(3-((trideuteriomethyl)oxy)propoxy)quinazolin-4-amine; Gefitinib Methyl-d3; ZD1839-d3; Iressa-d3; Gefitinib (methyl-D3); 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-[(trideuteriomethyl)oxy]propoxy]-
EINECS	Contact for details

Quality Control

Every batch of Gefitinib o-Methyl-D3 is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR, HPLC, and MS. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting identity, purity (by HPLC), isotopic enrichment, and related substance profiles. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 99.0 atom % D
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.