Please note, this OEL/ADE monograph also applies to Famotidine hydrochloride (CAS RN 125193-62-6). Famotidine is a propanimidamide and histamine H2-receptor antagonist with antacid activity. Famotidine is indicated in adult and pediatric patients 40 kg and greater for the treatment of active duodenal ulcer (DU), active gastric ulcer (GU), symptomatic nonerosive gastroesophageal reflux disease (GERD), and erosive esophagitis due to GERD. Famotidine is also indicated in adults for the treatment of pathological hypersecretory conditions (Zollinger-Ellison syndrome, multiple endocrine neoplasias), and for the reduction of the risk of duodenal ulcer recurrence.
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 Famotidine, 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.