Please note, this OEL/ADE monograph also applies to glycopyrronium bromide (CAS RN 51186-83-5), glycopyrrolate (CAS RN 596-51-0) and Glycopyrronium tosylate (CAS RN 1624259-25-1). 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.


CAS Registry Number:
Brand names:
Robinul®, Robinul Forte®, Cuvposa®, Glycate® Seebri Neohaler®
$679 USD


Why do you need this OEL Fastrac monograph?

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:

  • The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
  • A listing of all cited references utilized in the derivation of the OEL and ADE
  • An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

  • Fully documented. Over 20 pages in length, with calculations and cited references.
  • Save time! Unsurpassed delivery with instant download.
  • Save money. Similar documents cost 5-12 times as much.
  • Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Glycopyrronium, just click the ADD TO CART button.


If you're wondering about HBEL, we have something for you.

Search OEL Fastrac

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.
  • K. Rosenthal
  • Director of Manufacturing