Analytical reference standards of two potentially genotoxic impurities of lapatinib (Tykerb, Tyverb) are now available from Acanthus Research Inc.: Lapatinib Genotoxic Impurity 1 (CAS No. 202197-26-0) and Lapatinib Genotoxic Impurity 2 (CAS No. 443882-99-3). Both reference standards are of high purity and are accompanied by Certificate of Analysis.
Control of potentially genotoxic impurities in pharmaceutical products is mandated by European and North American regulatory agencies.
Lapatinib, marketed by GlaxoSmithKline under the proprietary names Tykerb (US) and Tyverb (Europe), is a targeted therapy for the treatment of women’s breast cancer and other solid tumors. It is a dual tyrosine kinase inhibitor disrupting both HER2/neu (Human EGFR type 2) and EGFR (epidermal growth factor receptor) pathways.