OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Sodium mephenamate (CAS RN 1804-47-3) and Mefenamate aluminum (CAS RN 39250-26-5). Mefenamic acid is a non-steroidal anti-inflammatory (NSAID) indicated for treatment of primary dysmenorrhea and relief of mild to moderate pain when therapy will not exceed seven days. Like that of other NSAIDs, the mechanism of action of mefenamic acid is not completely understood, but involves the binding of the prostaglandin synthetase receptors COX-1 and COX-2, inhibiting the action of prostaglandin synthetase. These receptors have a role as a major mediator of inflammation and/or a role for prostanoid signaling in activity-dependent plasticity and as a result, the symptoms of pain are temporarily reduced.

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 Mefenamic Acid, just click the ADD TO CART button.

HBEL

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