Please note, this OEL/ADE monograph also applies to scopolamine hydrobromide trihydrate (CAS RN 6533-68-2) and scopolamine base (CAS RN 51-34-3). Scopolamine hydrobromide is indicated for use in the treatment of motion sickness, excessive salivation, colicky abdominal pain, bradycardia, sialorrhea, diverticulitis, irritable bowel syndrome and motion sickness. It is also used to in the treatment of other forms of nausea and vomiting, is given as a preanesthetic sedative, and used to produce mydriasis and cycloplegia.
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:
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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.