Please note, this OEL/ADE monograph also applies to dipyrone sodium (CAS RN 68-89-3) and dipyrone sodium monohydrate (CAS RN 5907-38-0). Dipyrone, also known as metamizole, is a pyrazole that is antipyrine substituted at C-4 by a methyl(sulfomethyl)amino group. The sodium salt, dipyrone sodium, was widely used as a powerful analgesic and antipyretic, but it was withdrawn from many markets beginning in the 1970s due to a risk of causing agranulocytosis. It has a role as an antipyretic, an antirheumatic drug, a nonnarcotic analgesic, a nonsteroidal anti-inflammatory drug (NSAID), a peripheral nervous system drug, a prodrug and a cyclooxygenase (COX)-3 inhibitor. Approvals of the new drug application (NDA)'s for dipyrone drug products were withdrawn on June 27, 1977 and the product was withdrawn from the Canadian market in 1963.
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.