Please note, this OEL/ADE monograph also applies to metformin HCl (CAS RN 1115-70-4). Additionally, this monograph contains the pediatric ADE (pADE). Metformin is an agent belonging to the biguanide class of antidiabetics with antihyperglycemic activity. Metformin hydrochloride is indicated to improve glycemic control in adult patients with responsive, stable, mild, non-ketosis prone, type 2 diabetes mellitus (T2DM) as an adjunct to proper dietary management, exercise, and weight reduction, or when insulin therapy is not appropriate. Metformin can be used as monotherapy or in combination with other antidiabetic agents.
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 Metformin, just click the ADD TO CART button.
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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.