OEL Fastrac Catalog

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.

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 Amprolium, just click the ADD TO CART button.

HBEL

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