N-nitrosodimethylamine (NDMA), also known as dimethylnitrosamine, is a semivolatile, organic chemical that forms in both industrial and natural processes. It is not currently produced in pure form or used commercially in the United States, except for research purposes. It was formerly used in the production of rocket fuels and was used as an antioxidant, additive for lubricants, and a softening agent for copolymers. Evidence suggests that NDMA requires metabolic activation to exert its toxic and carcinogenic effects. NDMA undergoes oxidative demethylation which produces reactive intermediates. This causes methylation of DNA and mRNA leading to its ultimate carcinogenic and mutagenic effects. Subsequently, a number of investigators have linked the appearance of methylated DNA adducts derived from NDMA with the appearance of tumors. Both the ability of a tissue to metabolize NDMA and thereby generate DNA adducts, and the ability of the tissue to repair DNA adducts appear to play important roles in the mechanism of NDMA carcinogenicity.

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.


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$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 N-Nitrosodimethylamine, 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