Please note, this OEL/ADE monograph also applies to Exatecan mesylate anhydrous (CAS RN 169869-90-3), and Exatecan mesylate (CAS RN 197720-53-9). Exatecan, also known as DX 8951, is semisynthetic, water-soluble camptothecin derivative with antineoplastic activity. Exatecan mesylate is a semisynthetic, water-soluble derivative of camptothecin with antineoplastic activity. DE-310, a unique polymer prodrug of exatecan, which was developed to achieve protracted systemic exposure to the active drug after a single dose, is also undergoing early clinical development. Exatecan has been used in clinical trials studying the treatment of sarcoma, leukemia, lymphoma, lung cancer and liver cancer among others.
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), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Exatecan, just click the ADD TO CART button.
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Affygility Solutions’ 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.