Please note, this OEL/ADE monograph also applies to Dextropropoxyphene HCl (CAS RN 1639-60-7). Dextropropoxyphene, a schedule 4 controlled substance, is indicated for the treatment of mild to moderate pain. Only the dextro-isomer has an analgesic effect; the levo-isomer appears to exert an antitussive effect.
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:
The OEL/ADE monograph for Dextropropoxyphene is under development.
You can contact us and let us know if you'd like to be notified when this document becomes available.
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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.