Please note, this OEL/ADE monograph also applies to polypropylene glycol (CAS RN 25322- 69-4). Propylene glycol is an organic solvent and diluent used as a non-toxic antifreeze in breweries and dairies, in brake fluid, as a substitute for ethylene glycol and glycerol, and in manufacturing for synthetic resins. It is also added to foods as a humectant or solvent for artificial coloring or flavoring agents and is a component of cosmetic preparations. Propylene glycol is a solvent in many pharmaceuticals including oral, injectable, or topical formulations and appears to have preservative properties. The influence of the concentration of the co-solvent propylene glycol on the preservative efficacy of a complex pharmaceutical suspension-emulsion formulation containing methyl- and propylparaben was evaluated. It was determined that the co-solvent propylene glycol was at least of equal preservative importance than both parabens.
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.