Please note, this OEL/ADE monograph also applies to doxycycline hyclate (CAS RN 24390-14-5), doxycycline monohydrate (CAS RN 17086-28-1), doxycycline (CAS RN 10592-13-9), and doxycycline (CAS RN 94088-85-4). This monograph contains both the OEL and ADE. Doxycycline is a tetracycline derivative with uses similar to those of tetracycline (Tetracycline Phosphate Complex). It may be preferred to other tetracyclines in the treatment of sensitive infections because of its fairly reliable absorbtion and its long half-life which permits less frequent (often once daily) dosage. Doxycycline has antiprotozoal actions and may be given in conjunction with quinine in the management of falciparum malaria resistant to chloroquine (Doxycycline Hyclate). Tetracyclines are a broad spectrum bacteriostatic antibiotic. They are effective against rickettsia, spirochetes, mycoplasma, Bedsonia agents and susceptible strains of staphylococci, pneumococci, alpha and beta hemolytic streptococci, non-hemolytic streptococci and gram negative rods. The tetracyclines inhibit protein synthesis in susceptible organisms by preventing RNA translation. As chelating agents they interfere with calcium in bone and teeth.
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.