Icodextrin is a large molecular weight glucose polymer fraction used for continuous ambulatory peritoneal dialysis (CAPD) of diabetic patients and automated peritoneal dialysis (APD) for patients with end-stage renal disease. Icodextrin is dextrin, a glucose polymer, with more than 85% of its molecules with molecular weights between 1640 and 45000, and a weight-average molecular weight of about 20000 (martindale). Icodextrin functions as a colloid osmotic agent to achieve ultrafiltration during long peritoneal dialysis dwell. Icodextrin acts in the peritoneal cavity by exerting osmotic pressure across small intercellular pores resulting in transcapillary ultrafiltration throughout the dwell. It also contains electrolytes to help normalize electrolyte balance and lactate to help normalize acid-base status.
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 Icodextrin, just click the ADD TO CART button.
If you're wondering about HBEL, we have something for you.
Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
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.