OEL Fastrac Catalog

Cocos nucifera (coconut) oil, which is oil from the dried coconut fruit, is composed of 90% saturated triglycerides (2). For pharmaceutical applications, coconut oil is used as a basis for topical creams and ointments, in rectal and vaginal suppositories, and in solid dosage forms. Topical preparations have been used for pediculosis. Hydrogenated coco-glycerides are hard fats used in a pharmaceutical product as an excipient in suppositories. In cosmetic products, coconut oil is used as a cleanser, foaming agent, or stabilizer at concentrations up to 50%. It may function as a fragrance ingredient, hair conditioning agent, or skin conditioning agent and is reported in 626 cosmetics at concentrations from 0.0001% to 70%. Coconut oil is used in the manufacturing of soaps, edible fats, chocolate, candies, and candles. It is also used in place of lard in baking, in cotton dyeing, and as a base for ointments. The Food and Drug Administration (FDA) has determined that coconut oil is a food additive permitted for direct addition to food for human consumption as a substitute for cocoa butter. Coconut oil and its derivatives, coconut acid, hydrogenated coconut acid, and hydrogenated coconut oil, are used by industry as a convenient source of lowerchain- length 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 Coconut Oil, just click the ADD TO CART button.

HBEL

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