OEL Fastrac Catalog

Birch triterpenes, also known as birch bark extract (BBE) or triterpene extract (TE), is an herbal extract rich in triterpenoids. Some of the compounds identified in it include betulin, lupeol, betulinic acid, oleanolic acid, and erythrodiol. Birch triterpenes are obtained from the white part of the birch tree bark, and the main species of trees used for production are Betula pendula (silver birch) and Betula pubescens (white birch) although hybrids of both species are used as well. A gel preparation of birch triterpenes (10% of birch triterpene dry extract in sunflower oil, also known as Oleogel-S10®) is indicated for the topical treatment of partialthickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months old and older. This birch triterpene dry extract contains 84% to 95% triterpenes calculated as the sum of betulin, betulinic acid, erythrodiol, lupeol, and oleanolic acid.

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 Birch Triterpenes, just click the ADD TO CART button.

HBEL

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