Nitazoxanide is a redox-active synthetic nitrothiazolyl-salicylamide derivative and antiprotozoal agent indicated for the treatment of infectious diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Nitazoxanide is an antiprotozoal with a mechanism of action believed to be due to interference with the pyruvate ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction, which is essential to anaerobic energy metabolism. The enzyme, PFOR, is involved in carbon metabolism and oxidizes pyruvate to acetyl-CoA using ferredoxin as an electron acceptor in vivo. Nitazoxanide can act as an alternate electron acceptor for this enzyme and be activated.
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 Nitazoxanide, 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.