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.
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.