OEL Fastrac Catalog

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Sodium Hyaluronate, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.