Please note, this OEL/ADE monograph also applies to indomethacin sodium (CAS RN 74252-25-8). Indomethacin is an indole acid derivative and a NSAID (Non-steroidal Anti-inflammatory Drug). It is used to treat musculoskeletal and joint disorders including ankylosing spondylitis, osteoarthritis, rheumatoid arthritis, and acute gout, and in peri-articular disorders such as bursitis and tendonitis. It may also be used in inflammation, pain, and oedema following orthopaedic procedures, in mild to moderate pain in conditions such as dysmenorrhoea, and it has been administered in the management of postoperative pain as an adjunct to opioids, and in the treatment of fever. Indomethacin used as a sodium salt to close patent ductus arteriosus in premature infants. This compound is also used to treat preterm labor. Indomethacin is a nonsteroidal anti-inflammatory drug that has an unknown mechanism of action. However, the drug exerts anti-inflammatory, analgesic, and antipyretic effects inhibiting the synthesis of prostaglandin. Indomethacin prevents release of Lysosomal enzymes and stabilizes liver lysomes when exposed to labilizing conditions. Inhibition of CA2+ ion accumulation in injured tissue & CA2+ influx into stimulated smooth muscle by indomethacin have been reported. To order your OEL monograph, prepared by industry experts, and for instant download click on the "Order Now" button to the right.

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:
Indocid, Indocin
$639 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. 10-12 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 Indomethacin, 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