Sodium gluconate is the water-soluble organic sodium salt of D-gluconic acid. Gluconate salts are oxidation products of glucose and occur widely in nature. Sodium gluconate belongs to the hydroxycarboxylic acid salt family. The chemical structure of sodium gluconate consists of a six-carbon chain with five hydroxyl (-OH) groups terminating in a carboxylic acid group. The proximity of the oxygen atoms within the chemical structure lends to its function as a highly efficient chelating agent. Glucono-D-lactone is a cyclic ester (lactone) of D-gluconic acid. The lactone and the acid exist in equilibrium in aqueous solution, the toxicological effects of glucono-D-lactone, Dgluconic acid and sodium gluconate are expected to be very similar.
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:
To order an OEL/ADE monograph for Sodium Gluconate, just click the ADD TO CART button.
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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.