Please note, this OEL/ADE monograph also applies to trospium hydrochloride (CAS RN 10405-02-4). Trospium is indicated for the treatment of bladder muscle dysfunction, overactive bladder. Trospium, an antimuscarinic and antispasmodic agent, antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs. It also reduces smooth muscle tone in the bladder because of its parasympatholytic action. Trospium chloride has negligible affinity for nicotinic receptors at therapeutic doses.
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 and the acceptable surface limit (ASL).
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 Trospium, 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.