Please note, this OEL/ADE monograph also applies to isomer 2,4- dimethylpentane (CAS RN 108-08-7) and isomer 3,3- dimethylpentane (CAS RN 562-49-2). Heptane (also known as n-heptane), a hydrocarbon solvent, is typically isolated via fractional distillation from light naphtha petroleum streams. Heptane, in its various isomeric forms (including 2,4-dimethylpentane and 3,3-dimethylpentane), is a constituent of fuels and certain petroleum solvents. Furthermore, n-heptane is used as a standard in testing knock intensity of gasoline engines and is regulated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as an inert ingredient in non-food-use pesticides.
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.