Please note, this OEL/ADE monograph also applies to rosigiglitazone maleate (CAS RN 155141-29-0). Rosiglitazone is a anti-diabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Rosiglitazone maleate is an oral anti-diabetic drug of the thiazolidinedione class. It is an insulin sensitizing agent that primarily activates the peroxisome proliferator-activated receptor-gamma nuclear receptors, thereby, enhancing peripheral glucose utilization and improving glycemic control. It is also involved in the regulation of fatty acid metabolism.
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 Rosiglitazone, 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.