Please note, this OEL/ADE monograph also applies to Fluorometholone acetate (CAS RN 3801-06-7). Fluorometholone is a member of the class of glucocorticoids that is delta1-progesterone substituted at positions 11-beta and 17- by hydroxy groups, at position 6-alpha by a methyl group and at position 9- by a fluoro group. It has anti-inflammatory and antiallergic properties. Fluorometholone or fluorometholone acetate are indicated for the treatment of allergic and other steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eye.
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 Fluorometholone, 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.