Please note, this OEL/ADE monograph also applies to amprolium hydrochloride (CAS RN 137-88-2). Amprolium, as amprolium hydrochloride (HCl), is a veterinary coccidiostat that interferes with thiamine metabolism. Amprolium hydrochloride is indicated as a prophylactic or therapeutic agent for the treatment of coccidiosis in growing chickens, turkeys, laying hens, calves, sheep, goats and pigs. Amprolium hydrochloride is quaternized derivative, which is a thiamine antagonist. This blockage of receptors prevents coccidia from utilizing thiamine and as a result, thiamine is unavailable to coccidian (competitive inhibition of thiamine uptake). Thiamine pyrophosphate is a cofactor of several decarboxylase enzymes which play role in cofactor synthesis. It is the only agent that can be used in laying birds both for prevention and treatment of outbreaks. At higher doses, thiamine deficiency can occur in the host, but it can be prevented by the addition of thiamine.
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:
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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.