Copper gluconate is indicated for pesticide use in the United States, in dietary supplements as a readily assimilable form of copper, as oral deodorant, and as a feed additive. It is also used as a synergist and nutritional supplement for foods and for the prevention and treatment of copper deficiency. Copper-containing compounds are involved in oxidation-reduction reactions and react directly with molecular oxygen to produce reactive oxygen species. Copper gluconate is an orally bioavailable copper salt of D-gluconic acid that has a role as an enzyme cofactor for cytochrome C oxidase and superoxide dismutase. Additionally, copper forms complexes with thiocarbamate disulfiram (DSF). The DSF-copper complexes enhance specific proteasome inhibition, which may result in inhibition of cellular protein degradation, cessation of cell cycle progression, inhibition of cellular proliferation, and the induction of apoptosis in susceptible tumor cell populations. Copper also plays a catalytic role in oxygendependent reactions and is also an integral part of metalloenzymes, including monoamine oxidase, cytochrome oxidase, superoxide dismutase, and more.
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), and to obtain the following information:
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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.