Please note, this OEL/ADE monograph also applies to Zoledronate disodium anhydrous (CAS RN 131654-46-1), Zoledronate disodium (CAS RN 165800-07-7), Zoledronate trisodium (CAS RN 165800-08-8), Zoledronate trisodium anhydrous (CAS RN 827573-11-5), and Zoledronic acid trihydrate (CAS RN 904894-54-8). For the treatment of hypercalcemia of malignancy. Also for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. The drug is also approved for treatment of Paget’s Disease. Zoledronic acid, a member of bisphosphonate class, inhibits bone resorption. In vitro, zoledronic acid inhibits osteoclastic activity and induces osteoclast apoptosis. Zoledronic acid also blocks the osteoclastic resorption of mineralized bone and cartilage through its binding to bone, including osteoclastic activity and skeletal calcium release induced by various stimulatory factors released by tumors.
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.