Please note, this OEL/ADE monograph also applies to penethamate hydriodide (CAS RN 808-71-9). Penethamate is a prodrug which releases benzylpenicillin (Penicillin G). Benzylpenicillin is a known human skin and respiratory sensitizer. Additional precautions should be taken to protect from skin contact. Penethamate is the diethylaminoethyl ester of benzylpenicillin (penicillin G). It has the special ability to diffuse through cell membranes securing a rapid and even distribution throughout the tissue of the target organ. It is particularly suitable for the treatment of infections of the mammary, respiratory and uterine tissue. In formulations intended for veterinary use, the compound is incorporated as the hydroiodide. Penethamate hydriodide is used in intramammary products for treatment of mastitis in lactating cattle and as an injectable solution for the treatment of bacterial infections in swine, cattle, pigs and horses.
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.