OEL Fastrac Catalog

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. Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Dimethyl fumarate is also indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.

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 Dimethyl Fumarate, just click the ADD TO CART button.

HBEL

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