IMPORTANT Dimethyl fumarate (DMF) is a severe dermal sensitizer and advance precautions need to be taken before handling this compound in an occupational exposure setting. In addition, dimethyl fumarate is known to sublimate (going from the solid to gaseous phase without turning into a liquid). This has implications for containment,respiratory protection and industrial hygiene monitoring. The majority of material safety data sheets (MSDS) or safety data sheets (SDS) are inadequate in warning of the hazards of dimethyl fumarate. This occupational exposure limit monograph contains the most current health and safety information regarding dimethyl fumarate. Dimethyl fumarate is an investigational oral therapy in late-stage clinical development for the treatment of multiple sclerosis (MS).
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:
To order an OEL monograph for this compound, just click the ADD TO CART button.
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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.