Please note, this OEL/ADE monograph also applies to naloxegol oxalate (CAS RN 1354744-91-4). Naloxegol is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients. Naloxegol is mu-opioid receptor antagonist in the gastrointestinal tract, thereby decreasing the constipating effects of opioids. It has more than 6000-fold selectivity for the peripheral mu receptors and its “PEGylated” form restricts its action only to peripheral tissue without affecting the pain-relieving mechanism opioid in the central nervous system.
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 Naloxegol, 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.