OEL Fastrac Catalog

Potassium hydroxide, also known as lye, is an inorganic compound with the chemical formula KOH. Also commonly referred to as caustic potash, it is a potent base that is marketed in several forms including pellets, flakes, and powders. It is used in various chemical, industrial, and manufacturing applications. Potassium hydroxide is also a precursor to other potassium compounds. Potassium hydroxide is used in food to adjust pH, as a stabilizer, and as a thickening agent. This ingredient has been considered as generally recognized as safe (GRAS) as a direct human food ingredient by the Food and Drug Administration (FDA) based upon the observance of several good manufacturing practice conditions of use. In addition to the above uses, potassium hydroxide is also used in making soap, as an electrolyte in alkaline batteries, and in electroplating, lithography, and paint and varnish removers. Liquid drain cleaners contain 25% to 36% of potassium hydroxide. Medically, potassium hydroxide is widely used in the wet mount preparation of various clinical specimens for microscopic visualization of fungi and fungal elements in skin, hair, nails, and vaginal secretions. Recently, it has been studied for efficacy and tolerability in the treatment of warts. It was determined that topical KOH solution was found to be a safe and effective treatment of plane warts.

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 Hydroxide, just click the ADD TO CART button.

HBEL

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