Please note, this OEL/ADE monograph also applies to esomeprazole sodium (CAS RN 161796-78-7), esomeprazole strontium (CAS RN 934714-36-0), esomeprazole magnesium (CAS RN 217087-09-7, 161973-10-0) and esomeprazole dihydrate (CAS RN 217087-10-0). Esomeprazole is used in the treatment of erosive esophagitis and gastroesophageal reflux disease. It is also used in combination with antibiotics to treat certain types of ulcers. Esomeprazole is a proton-pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+ / K+ - ATPase in the gastric parietal cell. By acting specifically on the proton-pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
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 Esomeprazole, just click the ADD TO CART button.
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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.