Please note, this OEL/ADE monograph also applies to Alendronic acid monohydrate (CAS RN 138624-11-0), Alendronate sodium anhydrous (CAS RN 129318-43-0), alendronate sodium trihydrate (CAS RN 121268-17-5) Alendronate disodium (CAS RN 134606-40-9), Alendronate sodium monohydrate (CAS RN 260055-05-8), and Alendronate calcium (CAS RN 137504-90-6). Alendronic acid, also known as alendronate, is indicated to treat various forms of osteoporosis and Paget’s disease. Alendronic acid is a bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption. At the cellular level, it shows localization to sites of bone resorption and inhibits osteoclast resorption and activity. Alendronic acid does not interfere with osteoclast recruitment to attachment.
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 Alendronic acid, 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.