Please note, this OEL/ADE monograph also applies to azithromycin dihyrate (CAS RN 117772-70-0). Azithromycin a semi-synthetic macrolide antibiotic structurally related to erythromycin is indicated for the treatment of susceptible bacterial infection of multiple types including ear infection, lung infection, eye infection, sinus infection, gonorrhea, skin infection, and others. Azithromycin binds to the 50S ribosomal subunit of susceptible microorganisms; thus, interfering with microbial protein synthesis.
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.