Please note, this OEL/ADE monograph also applies to vonoprazan base (CAS RN 881681-00-1). Vonoprazan is an orally bioavailable potassium-competitive acid blocker (P-CAB) indicated for the treatment and prevention of acid-related diseases including erosive esophagitis, gastric ulcer, duodenal ulcer, peptic ulcer, gastro-esophageal reflux, reflux esophagitis and Helicobacter pylori eradication.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API).
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 monograph for Vonoprazan Fumarate, just click the ADD TO CART button.
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Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
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.