Please note, this OEL/ADE monograph also applies to rucaparib (CAS RN 283173-50-2). Rucaparib camsylate is the organic salt form of rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor. Rucaparib is indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. Rucaparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes. These enzymes play a role in DNA repair. In vitro studies suggest that rucaparib induced cytotoxicity is mediated through inhibition of PARP activity, which results in DNA damage, apoptosis and cell death.
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.