Manganese gluconate is currently only available in combination products. It is indicated for the prophylactic or nutrient supplement of manganese (2). The product is generally recognized as safe (GRAS) as a direct human food ingredient based upon use as a nutrient supplement and other food products as defined by the FDA code of federal regulations. Manganese gluconate is a salt that dissociates to manganese and gluconic acid in body fluids. Following dissociation, it acts as a manganese supplement in the body to help maintain plasma levels and prevent depletion of endogenous stores.
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:
To order an OEL monograph for this compound, just click the ADD TO CART button.
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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.