Description

Gefitinib CAS NO 184475-35-2 is a selective, small-molecule inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase. This targeted therapeutic agent is crucial for disrupting the signaling pathways that drive the proliferation and survival of certain cancer cells. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of oncology treatments, particularly for non-small cell lung cancer (NSCLC).

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in finished dosage forms for targeted cancer therapy.
• Oncology Research: A critical tool for in vitro and in vivo studies on EGFR mutation-driven cancers and drug resistance mechanisms.
• Reference Standard: Serves as a high-purity analytical standard for quality control testing in pharmaceutical laboratories.
• Formulation Development: Used in R&D for developing novel drug delivery systems, such as tablets or capsules.
• Bulk Drug Substance: Supplied to compounding pharmacies and generic drug manufacturers for final product assembly.
• Biochemical Pathway Inhibition: Employed in cell biology to study the EGFR signaling pathway and its role in tumorigenesis.

Basic Information

Item	Detail
Product Name	Gefitinib
CAS No.	184475-35-2
Molecular Formula	C22H24ClFN4O3
Molecular Weight	446.90 g/mol
Synonyms	ZD1839; Iressa; N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine; 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-; Gefitinib Hydrochloride (salt form); Gefitinib Anhydrous; Gefitinib Free Base
EINECS	Contact for details

Quality Control

Our Gefitinib is manufactured under strict quality management systems to ensure it meets the rigorous standards required for pharmaceutical use. Each batch is tested against comprehensive specifications, including identity, purity, and impurity profiles, utilizing advanced analytical techniques like HPLC and NMR. Certificates of Analysis (COA) documenting full compliance are provided with every shipment.

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 must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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