Please note, this OEL/ADE monograph also applies to Antazoline phosphate (CAS RN 154-68-7), Antazoline hydrochloride (CAS RN 2508-72-7), Antazoline mesylate (CAS RN 3131-32-6; 25138-84-5), Antazoline sulfate (CAS RN 84803-70-3; 24359-81-7) and Antazoline nitrate (CAS RN 145178-44-5). Antazoline is an ethylenediamine derivative and a member of the class of imidazolines. Antazoline is a first-generation antihistamine with anticholinergic activity. It was first described in the 1950s and was approved by the Food and Drug Administration (FDA) in the 1990s. Antazoline is used to relieve nasal congestion. It is also formulated as eye drops with naphazoline to relieve allergic conjunctivitis. The hydrochloride and sulfate salts of antazoline have been used topically for the treatment of minor skin irritations, but as with other antihistamines, there is a risk of sensitization. The hydrochloride has also been given orally.

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:
Trade names:
Arithmin®, Antastan®
$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 Antazoline, 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.
  • K. Rosenthal
  • Director of Manufacturing