[6] The United States Environmental Protection Agency (EPA) determined that the maximal admissible concentration of NDMA in drinking water is 7 ng/L.
[8] As of July 2020, the EPA has not set a regulatory maximal contaminant level (MCL) for drinking water.
11002), and is subject to strict reporting requirements by facilities that produce, store, or use it in significant quantities.
The limits for nitrosamines in medicines have been set using internationally agreed standards (ICH M7(R1)) based on lifetime exposure.
[15] In the laboratory, NDMA can be synthesised by the reaction of nitrous acid with dimethylamine: The mechanism of its carcinogenicity involves metabolic activation steps resulting in the formation of methyldiazonium, an alkylating agent.
In 1978, a teacher in Ulm, Germany, was sentenced to life in prison for trying to murder his wife by poisoning jam with NDMA and feeding it to her.
[16][17] That same year, Steven Roy Harper spiked lemonade with NDMA at the Johnson family home in Omaha, Nebraska.
[22] In December 2019, the FDA began testing samples of the diabetes drug metformin for NDMA.
[23] The FDA announcement followed a recall of three versions of metformin in Singapore, and the European Medicines Agency's request that manufacturers test for NDMA.
[28][32][33][34][35] In August 2021, a class 2 medicines recall was issued for a batch of metformin hydrochloride 500 mg/5ml Oral Solution from Rosemont Pharmaceuticals Limited, which was first distributed in December 2020, due to the identification of higher than acceptable levels of NDMA.
[36] A study has shown that NDMA perturbs arginine biosynthesis, mitochondrial genome maintenance, and DNA damage repair in yeast.