Alfacalcidol is an active metabolite of vitamin D, which performs important functions in regulation of the calcium balance and the bone metabolism. Alfacalcidol is indicated for use in all conditions where there is a disturbance of calcium metabolism due to impaired 1-α hydroxylation, such as when there is reduced renal function. The main indications include renal osteodystrophy, hyperparathyroidism (with bone disease), hypoparathyroidism, neonatal hypocalcemia, nutritional and malabsorptive rickets and osteomalacia, pseudodeficiency (D-dependent) rickets and osteomalacia, and hypophosphatemic vitamin D.
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), and to obtain the following information:
To order an OEL monograph for this compound, just click the ADD TO CART button.
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Affygility Solutions’s 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.