Please note, this OEL/ADE monograph also applies to citric acid anhydrous (CAS RN 77-92-9) and citric acid monohydrate. Citric acid solutions are systematic and urinary alkalinizing agents used for the treatment of chronic metabolic acidosis, particularly when caused by renal tubular acidosis; conditions when long-term maintenance of an alkaline urine is desirable, in treatment of patients with uric acid and cysteine stones in the urinary tract and in conjunction with agents that increase uric acid excretion in gout therapy to prevent uric acid based kidney issues.
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.