Description

Gefitinib n-Oxide is a key pharmaceutical intermediate and metabolite of the anticancer drug Gefitinib. This compound is of significant importance for research and development in the field of oncology, particularly in the study of drug metabolism and the synthesis of related active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic research institutions engaged in the development and quality control of tyrosine kinase inhibitor therapies.

Application

• Pharmaceutical Intermediate: Critical for the synthesis and scale-up production of Gefitinib and its derivative compounds.
• Metabolite Reference Standard: Used as an analytical standard in bioanalytical studies to identify and quantify Gefitinib metabolites in biological samples.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Essential for investigating the metabolic pathways, bioavailability, and excretion profiles of Gefitinib.
• Impurity Standard: Serves as a certified reference material (CRM) for monitoring and controlling process-related impurities in Gefitinib API manufacturing, ensuring final product quality.
• Preclinical and Clinical Research: Supports toxicology studies and clinical trial material characterization.
• Academic Research: Used in university and institutional labs for mechanistic studies on EGFR (Epidermal Growth Factor Receptor) inhibition and resistance.

Basic Information

Product Name	Gefitinib n-Oxide
CAS No.	847949-51-3
Molecular Formula	C₂₂H₂₄ClFN₄O₄
Molecular Weight	462.90 g/mol
Synonyms	Gefitinib N-Oxide; Gefitinib Impurity F; N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-4-quinazolinamine N-Oxide; 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-, 4-oxide; ZD1839 N-Oxide; Gefitinib Metabolite M1; Gefitinib Related Compound F
EINECS	Contact for details

Quality Control

Our Gefitinib n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and stringent control of residual solvents and heavy metals. We provide full traceability and Certificates of Analysis (COA) are available for all shipments, ensuring compliance with ICH guidelines and customer-specific requirements for pharmaceutical intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Single Maximum Impurity	≤ 1.0%
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.