Polysorbate 80 is used as a solubilizer, antimicrobial preservative, and as a disinfectant. It is a hydrophilic nonionic surfactant used widely as an additive in foods, pharmaceutical preparations, and cosmetics, as an emulsifier, dispersant, or stabilizer, and as a lubricant in eyedrops. Polysorbate 80 is a primary component in protein formulations and it inhibits potential interfacial damage of the protein molecule that undergoes mechanical stress during shipping and handling. It also affects formulation photostability. When exposed to light, polysorbate 80 in an aqueous solution results in peroxide generation, which may lead to oxidation of the susceptible amino acid residues in the protein molecule.
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:
To order an OEL monograph for this compound, just click the ADD TO CART button.
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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.