Cefcapene pivoxil hydrochloride (CAS RN 147816-23-7), and Cefcapene pivoxil monohydrate hydrochloride. Cefcapene pivoxil is the pivalate ester prodrug form of cefcapene, a semi-synthetic, thirdgeneration cephalosporin with antibacterial activity. After oral administration of cefcapene pivoxil, the ester bond is cleaved, releasing active cefcapene (1). Cefcapene pivoxil is usually used for the treatment of a wide range of bacterial infections including superficial skin infections, deep skin infections, lymphatics/lymphadenitis, chronic pyoderma, secondary infections such as trauma/burns and surgical wounds, mastitis, perianal abscess, pharyngeal/laryngitis, tonsillitis (including peritonsillitis and peritonsillar abscess), acute bronchitis, pneumonia, secondary infection of chronic respiratory lesions, cystitis, pyelonephritis, urethritis, cervicitis, cholecystitis, cholangitis, bartholinitis, intrauterine infection, uterine adnexitis, dacryocystitis, stye, tarsalitis, otitis externa, otitis media, sinusitis, periodontitis, pericoronitis, and jaw inflammation.
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.