Please note, this OEL/ADE monograph also applies to Glycopyrronium (CAS RN 596-51-0). Glycopyrronium bromide, the bromide salt of glycopyrrolate, is indicated for the treatment of cardiac dysrhythmia, drooling, peptic ulcer, premedication for anesthesia, reversal of neuromuscular blockade and chronic obstructive pulmonary disease (COPD). Glycopyrrolate is an anticholinergic agent which inhibits the acetylcholine activity on smooth muscles and structures innervated by postganglionic nerves. This results in a decreased volume and acidity of gastric secretions, as well as a control on excessive pharyngeal, tracheal and bronchial secretions. It is also used topically for treatment of hyperhydrosis and orally (tablet and suspension), for the treatment of stomach ulcers and excessive drooling. As an antimuscarinic agent, glycopyrrolate also antagonizes muscarinic symptoms which are induced by cholinergic medications.
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.