Please note, this OEL/ADE monograph also applies to cetrimide (CAS RN 8044-71-1), cetrimide hydrochloride (CAS RN 505-86-2), and cetrmonium bromide (CAS RN 57-09-0). Cetrimonium, a cetyltrimethylammonium compound, is an anti-infective agent whose salts and derivatives are used as topical antiseptics (1). Cetrimonium is the parent compound of cetrimide, which is an antiseptic used topically as a cream to help prevent infection in chapped hands, minor skin abrasions, minor cuts, burns and diaper rash (2, 3, 4). In veterinary medicine, cetrimide is used as a topical antiseptic at concentrations up to 2%. Cetrimide dissociates to a biologically active cation and an inactive anion in aqueous solution; the cation is responsible for the surfactant activity and anti-infective properties.
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), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Cetrimonium, just click the ADD TO CART button.
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Affygility Solutions’ 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.