OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to alternate CAS RNs 68459-23-4 or 84776-91-0. Soybean oil, or soy oil, is the fatty oil obtained from seeds of Glycine soja and Glycine max (Glycine hispida) by extraction and subsequent refining. It is available as the hydrogenated oil, partially hydrogenated oil, refined oil, or both refined and hydrogenated oil. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic, and stearic. Another source reported for Glycine soja (soybean) oil mean values of 2.9% to 12.1% of linolenic acid, 25% to 63.1% of linoleic acid, and 11.5% to 60% of oleic acid. Soybean oil is used in parenteral nutrition formulations as a source of calories and essential fatty acids.

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.

Please note: Due to the complexity and amount of studies regarding this compound—a Natural Health Product—increased cost is charged.

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 Soybean Oil, just click the ADD TO CART button.

HBEL

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