Please note, this OEL/ADE monograph also applies to Furaltadone hydrochloride (CAS RN 3759-92-0) and Furaltadone tartrate (CAS RN 14343-71-6). Furaltadone is a nitrofuran antibiotic that is effective against bacterial infections in birds when added to feed or drinking water. Furaltadone is also known as 5- (morpholinomethyl)-3-[(5-nitrofurfurylidene)amino]-2-oxazolidinone (MNAO). Its use in humans was stopped because of toxicity. Furaltadone had been approved for use in veterinary medicine, but the United Sates (US) Food and Drug Administration (FDA) has since withdrawn approval as a result of evidence of carcinogenicity (3). Furaltadone is indicated topically in some countries in combination with other drugs for the treatment of otitis media and otitis externa.
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 Furaltadone, 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.