OEL Fastrac Catalog

Leucine (L-leucine) is an aliphatic branched chain amino acid (BCAA) that is an essential constituent of the diet and is found in many foods. It is used as a dietary supplement and is also an ingredient of several preparations that have been promoted for disorders of the liver. It is indicated to assist in the prevention of the breakdown of muscle proteins that sometimes occur after trauma or severe stress. Leucine is one of the building blocks required for protein synthesis. Once in the body, leucine catabolism is initiated in muscle and yields NADH and FADH2, which can be utilized for ATP generation. The first step is a transamination using a single BCAA aminotransferase, with a-ketoglutarate as amine acceptor. As a result, an α-keto acid is produced and is oxidized using a common branched-chain α-keto acid dehydrogenase. Leucine gives rise to acetylCoA and aceto-acetylCoA and thus, is classified as strictly ketogenic.

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 Leucine, just click the ADD TO CART button.

HBEL

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