OEL Fastrac Catalog

Note, this OEL Fastrac monograph also covers the salt form of phenylephrine HCl (CAS RN 61-76-7), Phenylephrine bitartrate (CAS RN 17162-39-9; 13998-27-1), Phenylephrine tannate (CAS RN 1416-03-1) and includes the pediatric ADE. Phenylephrine is indicated for nasal congestion, glaucoma, low blood pressure, induction of pupil dilation, and inflammation of the iris. Phenylephrine hydrochloride, a synthetic sympathomimetic agent, is a powerful postsynaptic alpha-receptor agonist with minimal effect on the beta-receptors of the heart. It exhibits a rapid and moderately extended vasoconstrictor and mydriatic action. Its action in the heart includes elevation of the heart rate and reduction of cardiac output.

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 Phenylephrine, just click the ADD TO CART button.

HBEL

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