Please note, this OEL/ADE monograph also applies to R-baclofen (Arbaclofen CAS RN 69308-37-8) and Arbaclofen HCl (CAS RN 63701-55-3).Baclofen is a muscle relaxant and antispastic with oral therapy indicated for spasticity. The precise mechanism of action of baclofen has not been fully determined. Baclofen exerts its effects as an agonist at presynaptic GABA-B (bicuculline-insensitive) receptors. It acts mainly at the spinal cord level to inhibit the transmission of both monosynaptic and polysynaptic reflexes, possibly by hyperpolarization of primary afferent fiber terminals, resulting in antagonism of the release of putative excitatory transmitters (i.e., glutamic and aspartic acids).
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.