Please note, this OEL/ADE monograph also applies to the following CAS RN 175591-09-0 (hydrochloride), 1356475-57-4 (hydrobromide). Tapentadol is a centrally-acting synthetic analgesic. Immediate-release tapentadol is indicated for the management of moderate to severe acute pain in adults. Extendedrelease tapentadol is indicated for the management of pain that is opioid-responsive and severe enough to require daily, continuous, long-term opioid treatment, and for which alternative treatment options are inadequate. Extended-release tapentadol is also indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that is severe enough to require daily, around-the-clock, longterm opioid treatment and for which alternative treatment options are inadequate.
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 Tapentadol, just click the ADD TO CART button.
If you're wondering about HBEL, we have something for you.
Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
Affygility Solutions’s 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.