Please note, this OEL/ADE monograph also applies to Mirogabalin besylate (CAS RN 1138245-21-2). Mirogabalin is an orally administered gabapentinoid for the treatment of peripheral neuropathic pain (PNP), including diabetic PNP (DPNP) and postherpetic neuralgia. Mirogabalin exerts analgesic action by inhibiting calcium channels through binding to the α2δ-1subunit, which plays a supporting role in the function of voltage-gated calcium channels in the nervous system. Furthermore, it has been suggested that the analgesic action of mirogabalin is also involved in its activating action on the noradrenergic pathway of the descending pain inhibitory system. Mirogabalin has a unique binding profile and long duration of action.
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 Mirogabalin, 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.