OEL Fastrac Catalog

Nifurtimox is indicated for use in the treatment of American trypanosomiasis (Chagas’ disease) caused by T. cruzi. However, because of toxicity issues, benznidazole is the preferred treatment (2). Nifurtimox is not currently FDA approved and is available under an investigational protocol from the CDC. Nifurtimox is activated by a NADH-dependent mitochondrial nitroreductase, leading to the intracellular generation of nitro radical anions that are thought to account for the trypanocidal effects. The generated nitro anion radicals form covalent attachments to macromolecules leading to cellular damage that kills the parasites. Transfer of electrons from the activated drug regenerates the native nitrofuran and forms superoxide radical anions and other reactive oxygen species such as hydrogen peroxide and hydroxyl radical. The reaction of free radicals with cellular macromolecules results in cellular damage that includes lipid peroxidation and membrane injury, enzyme inactivation, and damage to DNA.

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 Nifurtimox, just click the ADD TO CART button.

HBEL

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