Please note, this OEL/ADE monograph also applies to umeclidinium bromide (CAS RN 869113-09-7). Umeclidinium is a muscarinic antagonist indicated for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Umeclidinium is a long-acting muscarinic antagonist used as a once-daily inhalation monotherapy or as a fixed-dose combination product with the long-acting β2 agonist vilanterol. Umeclidinium blocks the M3 muscarinic receptor which is highly expressed in airway smooth muscle, and inhibits the binding of acetylcholine, leading to bronchodilation.
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), and to obtain the following information:
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Affygility Solutions’s 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.