Please note, this OEL/ADE monograph also applies to the parent molecule levamisole (CAS RN 14769-73-4). Levamisole hydrochloride is an antihelmintic drug used to treat worm infestations, primarily in livestock. It is indicated in conjunction with fluorouracil as a chemotherapeutic against colon cancer. Levamisole is used off-label as an adjuvant therapy in children with pediatric nephrotic syndrome, it is registered as an orphan drug with the European Medicines Agency to treat Steroid-Sensitive Nephrotic Syndrome (SSNS); because of serious side effects (agranulocytosis) it was withdrawn from the market. More recently, there are increasing health concerns related to its use as an adulterant in cocaine.
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 Levamisole Hydrochloride, 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.