Please note, this OEL/ADE monograph also applies to Calcium beta-hydroxyisovaleric acid (CAS RN 135236-72-5). Beta-hydroxyisovaleric acid, also known as beta-hydroxy-beta-methylbutyrate (HMB), is a metabolite of the essential amino acid leucine. It is available as a free acid and as the calcium salt and is used as a nutritional supplement to increase muscle mass in muscle wasting conditions. HMB is synthesized endogenously in the body by a reversible transamination of leucine to alpha-ketoisocaproic acid by branched-chain amino acid aminotransferase which primarily occurs in skeletal muscle. HMB stimulates protein synthesis by upregulation of anabolic signaling pathways and decreases proteolysis by downregulation of catabolic signaling pathways, thereby affecting muscle protein turnover.
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:
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Affygility Solutions’ 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.