Alginic acid, also referred to as algin or alginate, is a hydrophilic or anionic polysaccharide isolated from certain brown seaweed (Phacophycae) via alkaline extraction. It is present in cell walls of brown algae where it forms a viscous gel when binding with water. Alginic acid is a linear polymer consisted of L-glucuronic acid and D-mannuronic acid residues connected via 1,4-glycosidic linkages. Available in different types of salt, alginic acid has been used in a variety of uses in food, cosmetics and pharmaceutical products for over 100 years. Alginic acid is a United States (US) Food and Drug Administration (FDA)-approved food ingredient in soup and soup mixes as an emulsifier, thickener, and stabilizer. It is also available in oral dietary supplements and is found in antacids such as Gaviscon® to inhibit gastroesophageal reflux (GERD) by creating a physical barrier in the presence of gastric acid. Alginate-based raft-forming formulations for the management of heartburn and gastric acid reflux have been used worldwide for over 30 years.
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 Alginic Acid, 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.