Granisetron is indicated for nausea and vomiting related to chemotherapy and radiation. Granisetron hydrochloride is a selective antagonist of 5-hydroxytryptamine(3) (5-HT(3)) receptors present peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone. Binding results in blockade of serotonin stimulation and subsequent vomiting triggered by emetogenic stimuli.
This OEL/ADE monograph cover both Granisetron and Granisetron HCL (CAS RN 107007-99-8).
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), and to obtain the following information:
The OEL/ADE monograph for Granisetron is under development.
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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.