Description

4-Defluoro-4-Hydroxy Gefitinib is a key pharmaceutical intermediate and metabolite of the anticancer drug Gefitinib. This compound matters for its critical role in drug metabolism studies, pharmacokinetic research, and the development of analytical reference standards. It is primarily needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of active pharmaceutical ingredients (APIs) and high-purity fine chemicals.

Application

• Primary reference standard for the analytical quantification of Gefitinib and its metabolites in biological matrices.
• Critical intermediate in the research, development, and synthesis of novel tyrosine kinase inhibitor analogs.
• Essential material for conducting drug metabolism and pharmacokinetic (DMPK) studies.
• Used in the preparation of impurity standards for quality control and regulatory compliance of Gefitinib API.
• Valuable tool compound for biochemical and pharmacological research targeting the epidermal growth factor receptor (EGFR).
• Key starting material for the synthesis of deuterated or other isotopically labeled versions of Gefitinib for advanced analytical applications.

Basic Information

Product Name	4-Defluoro-4-Hydroxy Gefitinib
CAS No.	847949-50-2
Molecular Formula	C22H24ClFN4O3
Molecular Weight	446.90 g/mol
Synonyms	4-Hydroxy Gefitinib; Gefitinib Impurity F; Gefitinib Metabolite M523595; Gefitinib Metabolite M1; N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-hydroxy-1-piperidinyl)propoxy]-4-quinazolinamine; 4'-Hydroxy Gefitinib; ZD1839 Metabolite; Iressa Metabolite
EINECS	Contact for details

Quality Control

Our 4-Defluoro-4-Hydroxy Gefitinib 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 related substances and residual solvents. We provide full traceability and Certificates of Analysis (COA) are available for all shipments, ensuring compliance with research and development grade specifications.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%
Total Impurities	≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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