Poliglusam (also known as chitosan), is a linear polysaccharide consisting of D-glucosamine and N-acetyl-D-glucosamine. Poliglusam is a naturally occurring substance that is found in the cell walls of fungi and in soil and sediments where it is produced from degradation of chitin induced by certain groups of bacteria that produce the enzymes deacetylase or chitosanase enzymes. In comparison, commercial poliglusam is derived from deacetylation of chitin contained in the shells of various sea crustaceans, such as shrimp. As a rich source of dietary fiber, chitosan is used as a food ingredient or additive. It is also reported to have an effect on protein aggregation, emulsification capacity, film-forming ability, clarifying ability, and fatty acid absorption capability. In addition, chitosan also exhibits antimicrobial and antioxidant activities.
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:
To order an OEL/ADE monograph for Poliglusam, just click the ADD TO CART button.
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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.