Please note, this OEL/ADE monograph also applies to alternate CAS RN 12597-37-4 and 90337-93-2. Silicon is a metalloid element that occurs widely in nature, mainly in the form of its compounds silicon dioxide and silicates. Silicon is a significant element that is essential for several physiological and metabolic processes. It is an essential trace element and has been used in nutritional supplements, usually complexed with amino acids to improve its bioavailability, or as its more soluble compounds, such as orthosilicic acid. Extracts of plants rich in silicon, such as equisetum have been used similarly. Silicon also has industrial uses, particularly in electronics. Silicon is also used to make silicon-oxygen polymers with methyl groups attached, known as silicones. Silicas and silicones also have pharmaceutical uses.
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, the acceptable surface limit (ASL), and the Permitted Daily Exposure (PDE) 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:
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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.