Please note, this OEL/ADE monograph also applies to sarecycline hydrochloride (CAS RN 1035979-44-2). Sarecycline is a tetracycline-class drug indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. The mechanism of action of sarecycline is unknown. It has been demonstrated that tetracyclines, like sarecycline, elicit their antimicrobial action by targeting and inhibiting protein synthesis in microbial agents like Cutibacterium acnes present in acne lesions. It is thought that the action of sarecycline revolves around the inhibition of various macromolecular biosynthesis activities like the macromolecular biosynthesis of microbial DNA and proteins. While sarecycline demonstrates appreciable inhibition of microbial macromolecular DNA and protein synthesis, it has little to no effect on lipid biosynthesis, cell wall synthesis, and RNA synthesis. Additionally, it is thought that tetracyclines like sarecycline can also affect an anti-inflammatory effect via the inhibition of the synthesis of inflammatory proteins generated by Cutibacterium acnes.
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.