OEL Fastrac Catalog

The major constituents in ginger rhizomes are carbohydrates (50% to 70%), which are present as starch. The concentration of lipids is 3% to 8% and includes free fatty acids (such as palmitic, oleic, linoleic, linolenic, capric, lauric, and myristic), triglycerides, and lecithins. Ginger contains volatile oils (approximately 1% to 3%) and nonvolatile pungent components (oleoresin). A variety of active components were identified in the oleoresin of ginger, including gingerols and shogaols. More than 400 different compounds have been identified in ginger. Therefore, chemical and physical characteristics are not applicable.

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 Ginger Extract, just click the ADD TO CART button.

HBEL

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