OEL Fastrac Catalog

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.

Why do you need this OEL Fastrac monograph?

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), as well as PIC/S and ANVISA requirements, and to obtain the following information:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Capecitabine, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.