Please note, this OEL/ADE monograph also applies to cCarboprost tromethamine (CAS RN 58551-69-2) and Carboprost methyl (CAS RN 35700-21-1). Carboprost tromethamine is indicated for the termination of pregnancy and for the treatment of refractory postpartum hemorrhage due to uterine atony that is not controlled by oxytocin and ergot preparations. Carboprost is a synthetic prostaglandin. It binds the prostaglandin E2 receptor, causing myometrial contractions, causing the induction of labor or the expulsion of the placenta. Prostaglandins occur naturally in the body and act at several sites in the body including the womb (uterus). They act on the muscles of the womb, causing them to contract. Carboprost tromethamine also stimulates the smooth muscle of the human GI tract, which may produce vomiting, diarrhea, or both.
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:
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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.