Please note, this OEL/ADE monograph also applies to L-Lactic acid (CAS RN 79-33-4). Lactic acid, L- is an intermediate in fermentation (oxidation, metabolism) of sugar. Typically, its concentrated form is used to prevent gastrointestinal fermentation. Other indicated uses are antimicrobial actives, chelating agents, preservatives and antioxidants, processing aids, and additives (2). Additionally, lactic acid is used in food and drugs as an antimicrobial agent, a curing and pickling agent, a flavor enhancer, a flavoring agent and adjuvant, a pH control agent, and as a solvent and vehicle.
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), and to obtain the following information:
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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.