OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Buspirone hydrochloride (CAS RN 33386-08-2). Buspirone is an anxiolytic agent and serotonin receptor agonist indicated to treat anxiety disorders or the short-term relief of symptoms of anxiety. Buspirone hydrochloride is an anxiolytic agent with a high affinity for 5-HT1A serotonin receptors, moderate affinity for dopamine type 2 (DA2) receptors, and no significant affinity for benzodiazepine receptors. It has no effect on GABA binding. The mechanism of action of buspirone is not fully elucidated. Buspirone acts as an agonist for the 5-HT1A receptors, and both an antagonist and agonist for DA2 receptors. The net result is that serotonergic activity is suppressed while noradrenergic and dopaminergic cell firing is enhanced.

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Buspirone, just click the ADD TO CART button.

HBEL

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