Please note, this OEL/ADE monograph also applies to risedronate sodium (CAS RN 115436-72-1). Risedronate is indicated to treat various forms of osteoporosis and Paget’s disease. Risedronate binds to bone hydroxyapatite, and at the cellular level, inhibits osteoclast activity, thereby modulating bone metabolism. Although the osteoclasts adhere normally to the bone surface, they show evidence of reduced active resorption by the lack of ruffled border. Risedronate is an antiresorptive agent. It has an affinity for hydroxyapatite and acts by inhibiting osteoclast-mediated bone resorption. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (for example, lack of ruffled border). Animal studies showed that risedronate treatment reduces bone turnover (activation frequency or the rate at which bone remodeling sites are activated) and decreases bone resorption at remodeling sites.
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.