Please note, this OEL/ADE monograph also applies to bicarbonate ion (CAS RN 71-52-3). Potassium bicarbonate is an aqueous salt solution of potassium and bicarbonate used in medicine as an antacid, electrolyte replenisher, and potassium supplement (1, 2, 3). It is indicated for the treatment of patients with hypokalemia, with or without metabolic alkalosis, and digitalis intoxication. The antacid potential of potassium bicarbonate is achieved by increasing the gastrointestinal pH by neutralizing hydrochloric acid. This results in the suppression of the action of pepsin which is the enzyme that exacerbates ulceration in the stomach (3). The potassium ion is a principal intracellular cation of most body tissues and an essential part of many physiological processes, including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of muscle, and the maintenance of normal renal function.
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.