Please note, this OEL/ADE monograph also applies to sultamicillin tosilate (CAS RN 83105-70-8). Sultamicillin tosilate is the salt form of sultamicillin. Sultamicillin is a double ester of sulbactam and ampicillin. Sultamicillin has been shown to be clinically effective in noncomparative trials in patients with infections of the respiratory tract, ears, nose and throat, urinary tract, skin and soft tissues, as well as in obstetric and gynecological infections, and in the treatment of gonorrhea. Sultamicillin is a double ester of sulbactam and ampicillin. The double ester form is orally bioavailable unlike the combination of sulbactam and ampicillin which is administered parenterally. Sultamicillin is hydrolyzed in the intestinal wall releasing sulbactam and ampicillin. The bactericidal activity of sultamicillin is primarily due to the ampicillin component of the molecule while the sulbactam component inhibits beta-lactamases.
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:
To order an OEL/ADE monograph for Sultamicillin, just click the ADD TO CART button.
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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.