Please note, this OEL/ADE monograph also applies to alternate CAS RN 6059-47-8, codeine citrate (CAS RN 5913-73-5), codeine hydrobromide (CAS RN 125-25-7), codeine hydrochloride (CAS RN 1422-07-7), codeine hydrochloride dihydrate (CAS RN 5916-29-0), codeine phosphate (CAS RN 41444-62-6), codeine phosphate sesquihydrate (CAS RN 5913-76-8), codeine sulfate anhydrous (CAS RN 1420-53-7), and codeine sulfate trihydrate (CAS RN 6854-40-6). Codeine is a schedule II controlled substance indicated for pain. Codeine has a potential for abuse and can cause physical and psychological dependence. Codeine is a narcotic, opioid analgesic which binds to the mu receptor as an opiate receptor agonist. Although the exact mechanism of analgesic action is unknown, it may come from its conversion to morphine. Codeine phosphate is also associated with antitussive effects via direct depression of the medullary cough reflex and appears to exert a drying effect on respiratory tract mucosa and to increase viscosity of bronchial secretions.

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:
$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 Codeine, 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