Please note, this OEL/ADE monograph also applies to Alvimopan monohydrate (CAS RN 1383577-62-5), Alvimopan dihydrate (CAS RN 170098-38-1), and Alvimopan sulfate disodium salt (CAS RN Not Available). Alvimopan is an opioid antagonist indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. Following oral administration, alvimopan antagonizes the peripheral effects of opioids on gastrointestinal motility and secretion by competitively binding to the gastrointestinal tract μ-opioid receptors. It binds to peripheral μ-receptors and dissociates slower than most other ligands. This selective gastrointestinal opioid antagonism is achieved without reversing the central analgesic effects of μ-opioid agonists.
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 Alvimopan, 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.