Please note, this OEL/ADE monograph also applies to Edetate disodium anhydrous (CAS RN 139-33-3), Edetate disodium dihydrate (CAS RN 6381-92-6), Edetate trisodium (CAS RN 150-38-9), Edetate trisodium monohydrate (CAS RN 10378-22-0), Edetate tetrasodium (CAS RN 64-02-8) Edetate trisodium monohydrate (CAS RN 10378-22-0), Edetate tetrasodium (CAS RN 64-02-8), and Edetate tetrasodium tetrahydrate (CAS RN 13235-36-4). Ethylenediaminetetraacetic acid (EDTA), also collectively known as edetate, and its salts are substituted diamines. These ingredients function as chelating agents by combining with polyvalent metal cations in solution to form soluble ring structures. Edetate (EDTA) and its salts have uses in foods, pharmaceutical products, manufacturing, and are used to treat heavy metal poisoning and to reduce blood cholesterol.
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 Edetate Sodium, just click the ADD TO CART button.
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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.