Please note, this OEL/ADE monograph also applies to ertugliflozin pidolate (CAS RN 1210344-83-4). Ertugliflozin belongs to the class of potent and selective inhibitors of the sodiumdependent glucose cotransporters (SGLT); more specifically, the type 2, which is responsible for about 90% of the glucose reabsorption from the glomeruli (2). As monotherapy, ertugliflozin is indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus, in which metformin is inappropriate due to contraindications or intolerance (3, 4). Ertugliflozinn is also indicated in adult patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin or metformin and sitagliptin.
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 Ertugliflozin, 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.