Please note, this OEL/ADE monograph also applies to glycerol alpha, alpha' (CAS RN 4740-78-7) and to (CAS RN 86687-05-0). Glycerol formal is the condensation product of glycerin and formaldehyde (1,3-dioxan-5-ol; 1,3-dioxolan-4-ymethanol). It is a monovalent alcohol, linked with a cyclic ether group (1, 2, 3). Glycerol formal is usually composed of a mixture of two isomers, 4-hydroxymethyl-1,3- dioxolane (CAS# 5464-28-8) and 5-hydroxy-1,3- dioxane (CAS# 4740-78-7). These isomers are present in a constant ratio of 40% to 60%, respectively.
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.