Please note, this OEL/ADE monograph also applies to Hydromethylthionine mesylate (CAS RN 1236208-20-0). Hydromethylthionine (also known as leuco-methylthioninium (LMT) or leucomethylene blue) is a member of the class of phenothiazines that is 10H-phenothiazine in which the ring hydrogens at positions 3 and 7 have been replaced by dimethylamino groups. It has a role as a fluorochrome, a bacterial xenobiotic metabolite, a rat metabolite, and a mouse metabolite. It is a member of phenothiazines, an aromatic amine, and a tertiary amino compound. Hydromethylthionine is currently under investigation for Alzheimer’s disease (AD) and behavioral variant frontotemporal dementia (bvFTD).
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:
The OEL/ADE monograph for 613-11-6 is under development.
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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.