General Information

Gefitinib Impurities and Gefitinib 

Daicel Pharma synthesizes high-quality Gefitinib impurities like O-Desmethyl Gefitinib, Gefitinib 3,4-Difluoro Impurity, Gefitinib Impurity 13 (Deschloro impurity), Gefitinib EP Impurity B, and more, which are crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient Gefitinib. Moreover, Daicel Pharma offers custom synthesis of Gefitinib impurities and delivers them globally.

Gefitinib [CAS: 184475-35-2] is an anilinoquinazoline compound to fight cancer. It treats non-small cell lung cancer. It is an epidermal growth factor kinase inhibitor and an antineoplastic agent.

Gefitinib: Use and Commercial Availability  

Gefitinib treats advanced non-small cell lung cancer (NSCLC) and other types of cancer. The drug is available under the brand name Iressa.

Gefitinib Structure and Mechanism of Action

The chemical name of Gefitinib is N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-4-quinazolinamine. Its chemical formula is C₂₂H₂₄ClFN₄O₃, and its molecular weight is approximately 446.9 g/mol.

Gefitinib inhibits tyrosine-kinases associated with the epidermal growth factor receptor (EGFR-TK), thus inhibiting the growth of cancer cells. However, the clinical antitumor action of Gefitinib is not fully characterized.

Gefitinib Impurities and Synthesis

Gefitinib impurities can be formed during manufacturing¹ or storage. The impurities include degradation products, starting materials, and other process-related impurities. Their formation can affect the quality, safety, and efficacy of the drug, and thus their identification and control are critical in drug development and manufacturing. Various analytical techniques, such as HPLC and LC-MS, helps detect and quantify impurities in Gefitinib.

Daicel offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for Gefitinib impurity standards, O-Desmethyl Gefitinib, Gefitinib 3,4-Difluoro Impurity, Gefitinib Impurity 13 (Deschloro impurity), Gefitinib EP Impurity B, and so on. The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We also provide 13C-DEPT and CHN if requested. We give a complete characterization report on delivery. Daicel has the technology and expertise to prepare any unknown Gefitinib impurity or degradation product. We also provide labeled compounds³ to quantify the efficacy of Gefitinib. Daicel offers Gefitinib-D3, a deuterium-labeled Gefitinib standard used in bio-analytical research, such as BA/BE studies with isotope data in CoA.