N-Nitrosodimethylamine (NDMA)

July 30, 2025

Recently, drug regulator DCGI has asked drug controllers of all States and Union Territories to direct manufacturers under their jurisdiction to monitor the presence of a potentially carcinogenic chemical -- N-Nitrosodimethylamine -- in antacid Ranitidine.

About N-Nitrosodimethylamine:

  • It is a volatile organic chemical that occurs widely in the environment due to its ready formation from commonly found precursors.
  • It is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies.
  • NDMA are formed when a secondary or tertiary amine reacts with a nitrite ion under acidic conditions.
  • Features of N-Nitrosodimethylamine
    • It is a yellow, odourless liquid chemical once used to make rocket fuel.
    • It is also a byproduct of several manufacturing processes and water chlorination.
    • NDMA breaks down when sunlight hits it.
    • Normally, people are exposed to small amounts of NDMA in the environment and through food and water.
    • Chemicals found in food and water, such as nitrosamines or alkylamines, can turn into NDMA in the stomach.
    • NDMA is also created when food or drink is processed. Foods such as cured meats (particularly bacon), beer, fish, cheese and even vegetables may contain NDMA.
    • Some people may have had exposure to NDMA through the use of contaminated medications
  • Applications: Historically it was commercially used in the production of rocket fuel, antioxidants, softeners for copolymers, and additives for lubricants.

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