Please note, this OEL/ADE monograph also applies to etidronate sodium (CAS RN 7414-83-7). Etidronic acid is a bisphosphonate used as a medication, detergent, water treatment, and cosmetic. Etidronic acid and its salts are used to treat bone diseases characterized by osteoclastic bone resorption. As an oral medication, etidronate disodium is indicated for the treatment of symptomatic Paget’s disease of bone and in the prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury. In combination with calcium carbonate, etidronate disodium is indicated for the treatment of established postmenopausal osteoporosis, for the prevention of osteoporosis in postmenopausal women who are at risk of developing osteoporosis and for the prevention of corticosteroid induced osteoporosis.
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.