Please note, this OEL/ADE monograph also applies to sodium bisulfite (CAS RN 7631-90-5), sodium metabisulfite (CAS RN 7681-57-4), and sodium sulfite heptahydrate (CAS RN 10102- 15-5). Sodium sulfite is an inorganic sodium salt having sulfite as the counterion. It has a role as a food preservative and a reducing agent. Sodium bisulfite (also known as sodium hydrogensulfite) is an inorganic sodium salt having hydrogensulfite as the counterion. It has been used externally for parasitic skin diseases and as a gastrointestinal (GI) antiseptic. Sodium bisulfite is an ingredient in parenteral nutrition products for patients with severe liver disorders. In petroleum technology, sodium sulfite is used as an oxygen scavenger.
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:
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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.