OEL Fastrac Catalog

Ivy leaf extract taken from hedera helix L. folium is used as an expectorant in cases of productive cough. It has been used to treat chronic asthma for many years. Ivy leaf has been used for centuries to treat diverse diseases. It has been evaluated for its usefulness in treating upper respiratory infections. Information on the mechanism of action of the all the components of ivy leaf could not be located. Saponines are considered the primary component responsible for the broncholytic and secretolytic efficacy of ivy leaves. Specific saponines prevent internalization of B2- adenergic receptors on the surface of bronchial smooth muscle cells and alveolar type II cells.

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 Ivy Leaf Extract, just click the ADD TO CART button.

HBEL

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