Please note, this OEL/ADE monograph also applies to naftifine hydrochloride (CAS RN 65473-14-5). Naftifine, an antifungal drug, is approved to treat athlete’s foot (tinea pedis), but may also be effective against jock itch and ringworm. Naftifine is a synthetic allylamine antifungal agent. The exact mechanism of action against fungi is not known. Naftifine appears to interfere with sterol biosynthesis by inhibiting 2, 3 epoxidase resulting in a decrease in the amount of sterols, especially ergosterol and accumulation of squalene in the fungal cells.
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 Naftifine, 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.