Please note, this OEL/ADE monograph also applies to hyaluronic acid (CAS RN 9004-61-9). Sodium hyaluronate is the sodium salt of hyaluronic acid. It is a glycosaminoglycan consisting of D-glucuronic acid and N-acetyl-D-glucosamine disaccharide units. It is extracted from cockscombs or obtained by fermentation from streptococci. A viscous solution of sodium hyaluronate is used during surgical procedures on the eye, such as for cataract extraction. Introduction of the solution via a fine cannula or needle allows tissues to be separated during surgery and protects them from trauma. Sodium hyaluronate eye drops are also used for the relief of dry eye and as a contact lens lubricant. It is also used in the intra-articular treatment of osteoarthritis of the knee, for managing lesions of the oral mucosa, and as a temporary replacement of the glycosaminoglycan layer in the bladder for the symptomatic treatment of interstitial cystitis.
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 Sodium Hyaluronate, 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.