Please note, this OEL/ADE monograph also applies to upadacitinib tartrate tetrahydrate (CAS RN 1607431-21-9), upadacitinib hemihydrate (CAS RN 2050057-56-0), and upadacitinib tartrate anhydrous (CAS RN 2095311-41-2). Upadacitinib is an oral selective inhibitor of Janus-associated kinase 1 (JAK-1). It is indicated for the treatment of moderately-to-severely active rheumatoid arthritis (RA) or active psoriatic arthritis in adult patients who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs) such as methotrexate or tumor necrosis factor (TNF) blockers. In Europe, upadacitinib may be used as monotherapy or in combination with methotrexate (MTX) for RA or psoriatic arthritis.
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 Upadacitinib, 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.