OEL Fastrac Catalog

Moxonidine is indicated for the management of mild to moderate essential or primary hypertension in adults. In different animal models, moxonidine has been shown to be a relatively potent antihypertensive agent. Available experimental data suggest that the site of the antihypertensive action of moxonidine is the central nervous system (CNS). Moxonidine has been shown to bind to I1-imidazoline receptors and to a lesser extent α2-adrenoreceptors. The therapeutic action of moxonidine appears to result from interaction with I1 and α2- receptors located within the rostral ventrolateral medulla, leading to a reduced activity of sympathetic nerves.

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 Moxonidine, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.