OEL Fastrac Catalog

Potassium bromide is a salt indicated for the treatment of epilepsy. It is used in veterinary medicine as a hypnotic and sedative in cattle, horses, sheep, and pigs. It is also used as an adjunct treatment of colic and tetany in horses and acetonemia in cattle. In dogs, potassium bromide is used as an anticonvulsant to treat seizure disorders. In addition to pharmaceutical use, potassium bromide is an active ingredient in two registered pesticide products with the US Environmental Protection Agency (EPA). Potassium bromide is an inorganic salt that dissociates into its potassium and bromide ions in aqueous solutions. The mechanism of action of bromide has not been clearly defined. It is proposed that bromide may aid in controlling seizures through hyperpolarization of neuronal cell membranes by preferential movement across gamma-amino butyric (GABA)- activated chloride channels, leading to stabilization and decreased sensitivity of epileptic foci.

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 Bromide, just click the ADD TO CART button.

HBEL

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