OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to potassium carbonate (CAS RN 584-08-7), bicarbonate water potassium (CAS RN Not Available), and 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. 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. 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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Potassium Bicarbonate, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.