Please note, this OEL/ADE monograph also applies to fludrocortisone acetate (CAS RN 514-36-3). Fludrocortisone is indicated for the treatment of Addison’s disease involving adrenal insufficiency. Fludrocortisone acetate, a synthetic adrenocortical steroid, possesses a very potent mineralocorticoid property and high glucocorticoid activity but is used only for its mineralocorticoid effects. It is believed to act by controlling the rate of protein synthesis. In small doses, it produces marked sodium retention and increased urinary potassium excretion while in large doses, it inhibits endogenous adrenal cortical secretion, thymic activity, and pituitary corticotropin excretion.
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:
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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.