Afatinib is an oral tyrosine kinase inhibitor used to treat non-small cell lung cancer (NSCLC) with specific EGFR mutations. It irreversibly blocks EGFR, HER2, and HER4 receptors to inhibit cancer cell growth. It is used when tumors are resistant to first-generation EGFR inhibitors. Common side effects include diarrhea, rash, and stomatitis.
Cleanchem is a trusted provider of premium pharmaceutical reference materials, specializing in Afatinib and its associated compounds. Our catalog includes pharmacopeial and non-pharmacopeial Afatinib impurities, metabolites, nitrosamine derivatives (N-NO compounds), and stable isotope-labeled products. These reference standards play a critical role in pharmaceutical R&D, supporting activities such as product formulation, ANDA and DMF submissions, quality assurance, analytical method development, and stability assessments.
All Afatinib-related substances undergo comprehensive characterization and are delivered with complete Certificates of Analysis and supporting analytical documentation to ensure regulatory adherence. Upon request, we can offer EP/USP traceable standards. Our products are routinely re-evaluated to maintain consistent quality and performance.