Please note, this OEL/ADE monograph also applies to phenobarbital base (CAS RN 50-06-6). Phenobarbital sodium is a barbiturate used in the treatment of epilepsy, anxiety, insomnia and convulsions. Phenobarbital sodium effects on the central nervous system (CNS) may be related to enhancement of activity of GABA, the principal inhibitory neurotransmitter in the CNS and/or an impairment of nerve impulse propagation through changes in ion channels leading to depression of sensory cortex of the brain, decreased motor activity and altered brain function.
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 Phenobarbital Sodium, 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.