Please note, this OEL/ADE monograph also applies to ulipristal acetate (CAS RN126784-99- 4). Ulipristal is a selective progesterone receptor modulator with antiprogesterone activity used for the purposes of emergency contraception after unprotected intercourse or possible contraceptive failure when administered within 120 hours (5 days). Ulipristal is also indicated for preoperative treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age and for intermittent treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.
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 Ulipristal, just click the ADD TO CART button.
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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.