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.
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:
To order an OEL/ADE monograph for Leucine, just click the ADD TO CART button.
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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.