Please note, this OEL/ADE monograph also applies to sodium citrate dihydrate (CAS RN 6132-04-3). Bicarbonate-providing salts, including sodium citrate, act as alkalinizing agents for various indications including correction of metabolic acidosis, alkalinization of urine, as an antacid, and as a buffering agent in pharmaceutical preparations. Sodium citrate may be used to neutralize acidic urine or to relieve discomfort in mild urinary tract infections; it has also been used for its anti-clotting properties as an anticoagulant in solutions, and in plasmapheresis. Eye drops containing sodium citrate (10%) have been used in the treatment of chemical eye burns.
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.