See OEL Fastrac listing for cholecalciferol. WARNING - Adverse effects from occupational exposure to vitamin D3 have been occurred. Cholecalciferol is used to prevent vitamin D deficiency or rickets. Vitamin D3 is hydroxylated in the kidney to yield 1,25- dihydroxycholecalciferol, or calcitriol, which is a physiologic regulator of calcium absorption. The principal biologic function of vitamin D is to maintain serum calcium and phosphorus concentrations within the normal range by enhancing the efficiency of the small intestine to absorb these minerals from the diet. Calcitriol (activated vitamin D) enhances the efficiency of intestinal calcium absorption along the entire small intestine, but principally in the duodenum and jejunum. Calcitriol also enhances phosphorus absorption along the entire small intestine, but principally in the jejunum and ileum. The activated forms of ergocalciferol, doxercalciferol, and cholecalciferol may have a negative feedback effect on parathyroid hormone production. The most two important mechanisms by which vitamin D acts to maintain normal concentration of calcium and phosphate in plasma are to facilitate their absorption by the small intestine and to enhance their mobilization from bone.
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:
The OEL/ADE monograph for Vitamin D3 is under development.
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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.