Determinations of N-nitrosodimethylamine
at part-per-trillion concentrations in contaminated groundwaters and drinking waters featuring carbon-based membrane extraction disks.
From these results, we observe that each gram of the sample produces 1.1 ppb of N-nitrosodimethylamine
(NDMA) and 0.9 ppb N-nitrosomorpholine (NMOR) when air is used as the sampling gas.
Kuo pointed out that N-Nitrosodimethylamine
and N-Nitrosodiethylamine are animal carcinogens and research has not yet indicated whether they are harmful to the human body or not.
Recalled by the European Medicines Agency in July 2018, Valsartan has been found carrying N-Nitrosodimethylamine
(a carcinogen); hence, it has been abruptly halted from distribution.
Finished products that are manufactured by API source other than those mentioned above can be sold in the market by all manufacturers, but they should initiate testing to confirm the absence of the N-Nitrosodimethylamine
(NDMA) impurity in the finished product and submit test reports within 3 months.
The problem: an impurity called N-nitrosodimethylamine
, or NDMA, which, the agency says, is classified as a probable human carcinogen.
The impurity detected in the API is N-nitrosodimethylamine
, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer classification.
This recall is due to an impurity, N-nitrosodimethylamine
, which was found in the recalled products.
The ministry's action follows a report by the European Medicines Agency indicating contamination of the active ingredient with N-nitrosodimethylamine
(NDMA), a chemical that might cause cancer.
Because of its critical nature, N-nitrosodimethylamine
(NDMA) was also included.
For instance, the carcinogen N-nitrosodimethylamine
, a disinfectant by-product of wastewater treatment, breaches reverse osmosis membranes.