Osimertinib

Osimertinib Impurities

Osimertinib impurities include synthetic intermediates, process-related compounds, and degradation products that may arise during synthesis, formulation, or storage. As a third-generation EGFR tyrosine kinase inhibitor used in the treatment of non-small cell lung cancer (NSCLC), impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Osimertinib EP Impurities

We offer pharmacopeial and non-pharmacopeial Osimertinib impurity compounds that conform to European Pharmacopoeia (EP) specifications. These standards support method development, impurity profiling, and stability studies. EP traceable compounds are available upon request and are supplied with validated analytical data including HPLC purity, NMR, and MS characterization.

Osimertinib Related Compounds

Our catalog includes structurally related compounds and synthetic intermediates associated with Osimertinib. These compounds are used in forced degradation studies, impurity identification, and toxicological qualification. Related substances may include N-oxide derivatives, dimeric forms, acrylamide analogs, halogenated variants, and stereoisomeric forms. All entries are supported by comprehensive analytical documentation and meet international regulatory expectations.

Osimertinib Impurity Reference Standards

Osimertinib impurity reference standards are supplied with validated analytical data including NMR, MS, and HPLC purity. These compounds are used in pharmaceutical R&D, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request. All products are re-tested at regular intervals to ensure consistency and reliability.