Please note, this OEL/ADE monograph also applies to benzhydrocodone hydrochloride (CAS RN 1379679-42-1). Benzhydrocodone is a benzylic prodrug of hydrocodone. It was developed in an effort to reduce parenteral bioavailability of the active metabolite as a deterrent to abuse. Benzhydrocodone is indicated for use in the short-term management of pain. Benzhydrocodone in combination with acetaminophen is marketed under the trade name Apadaz® and generic formulations are available. Benzhydrocodone is not reported to have pharmacological activity of its own and is not present in the plasma at detectable concentrations. Its active metabolite, hydrocodone, is a mu-opioid receptor agonist.
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 Benzhydrocodone, 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.