Please note, this OEL/ADE monograph also applies to Dexrabeprazole sodium (CAS RN 171440-18-9). Dexrabeprazole, also known as (R)-Rabeprazole, is a derivative of timoprazole used in the treatment of gastroesophageal reflux disease (GERD), stomach ulcers, and Zollinger-Ellison syndrome. Dexrabeprazole is the R enantiomer of the racemate rabeprazole. Rabeprazole, as a racemic mixture, is a gastric proton pump inhibitor which suppresses gastric acid secretion by inhibiting the gastric hydrogen-potassium adenosine triphosphatase (H+/K+ATPase) at the secretory surface of the gastric parietal cell. It does not exhibit anti-cholinergic or histamine H2 receptor antagonist properties.
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 Dexrabeprazole, 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.