Capecitabine is an antineoplastic agent marketed as Xeloda® for the treatment of colorectal and breast cancer. Capecitabine is a fluoropyrimine carbamate and is metabolized to 5-fluorouracil.Capecitabine is relatively noncytotoxic in vitro; its activity occurs after in vivo conversion to 5-fluorouracil (5-FU; fluorouracil), which in turn is converted to 5-fluoro-2-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate, (FUTP). The cytotoxic effect is produced by two different mechanisms. First, FdUMP and the folate cofactor N 5-10-methylenetetrahydrofolate bind to thymidylate synthase to form a ternary complex, thereby inhibiting thymidylate formation. Thymidylate is the precursor of thymidine triphosphate, which is essential for DNA synthesis; deficiency of this precursor leads to inhibition of cell division. Second, nuclear transcriptional enzymes can incorporate FUTP instead of uridine triphosphate during RNA synthesis, resulting in a metabolic error that interferes with RNA processing and protein synthesis.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), and to obtain the following information:
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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.