Please note, this OEL/ADE monograph also applies to sodium thioctate (CAS RN 2319-84- 8). Please note that this also covers CASRN 62-46-4. Thioctic acid, also known as (R,S) alpha-lipoic acid or (R,S) ALA, is a type of antioxidant and chemoprotective agent used for its antioxidant effects. Several studies have shown that thioctic acid has a beneficial effect on diabetes complications, diabetic neuropathy, cancer, glaucoma, liver disease/dysfunction, and in subacute necrotizing encephalopathy. Thioctic acid may also been used as an antidote to poisonous mushrooms (amanitin species); beneficial results have been claimed in amanitin poisoning after ingestion of the mushroom Amanita phalloides, but such use is controversial.
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:
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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.