Please note, this OEL/ADE monograph also applies to cetylpyridinium anhydrous chloride (CAS RN 123-03-5), cetylpyridinium chloride monohydrate (CAS RN 6004-24-6), cetylpyridinium bromide (CAS RN 140-72-7), cetylpyridinium acetate (CAS RN 7439-73-8), cetylpyridinium iodide (CAS RN 2349-55-5), cetylpyridinium bromide hydrate (CAS RN 202869-92-9), cetylpyridinium phosphate (CAS RN Not Available), cetylpyridinium oxalate (CAS RN Not Available), cetylpyridinium naphtholate (CAS RN Not Available), cetylpyridinium ammonium chloride (CAS RN Not Available), cetylpyridinium salicylate (CAS RN Not Available), cetylpyridinium tetraphenylborate (CAS RN Not Available), cetylpyridinium hydrogensulfate (CAS RN Not Available), and cetylpyridinium pertechnetate (CAS RN Not Available), Cetylpyridinium is a quaternary cationic bactericidal surfactant used as a topical antiseptic for skin, wounds, mucous membranes, and as a component in mouthwash, toothpaste, and lozenges as an antiseptic, treatment of gingivitis, and plaque prevention. It has been shown to be effective in preventing dental plaque and reducing gingivitis. It has also been used as an ingredient in certain pesticides.

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:
Aktivex, Biosept, Cepacol, Dobendan, Medilave, Pristacin
$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 Cetylpyridinium, 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