Please note, this OEL/ADE monograph also applies to Ezetimibe glucuronide (CAS RN 190448-57- 8). Ezetimibe is an inhibitor of intestinal cholesterol absorption. It is used, alone or with statins, to reduce total cholesterol, low-density lipoprotein (LDL)-cholesterol, and apoliopoprotein B in the management of hyperlipidaemias (an excess of lipids in plasma). Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. Ezetimibe localizes and appears to act at the brush border of the small intestine, leading to a decrease in the delivery of intestinal cholesterol to the liver. This causes a reduction of hepatic cholesterol stores and an increase in clearance of cholesterol from the blood.
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 Ezetimibe, 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.