FDA Releases Testing Method for NDMA Contamination
August 24, 2018 – As recalls of valsartan-containing products continue, the U.S. FDA has announced a testing method that allows manufacturers and regulators to detect N-nitrosodimethylamine (NDMA) contamination in valsartan drugs and active pharmaceutical ingredients (API).
The testing method is known as the gas chromatography-mass spectrometry (GC/MS) headspace method. The FDA’s Office of Testing and Research (OTR) developed the method in response to the discovery of NDMA in a valsartan API from Zhejiang Huahai Pharmaceutical in July 2018.
In addition to detecting the presence of NDMA in product samples, the test also helps determine the level of contamination. These levels have varied in the valsartan-containing products recalled to date due to the presence of NDMA impurities.
Full details on the testing procedure can be obtained from the FDA’s website at: