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Detection and Analysis of N-nitrosodimethylamine in Ranitidine by using Q Exactive Focus High Resolution Mass Spectrometry

This paper presents a highly sensitive detection method for  the analysis of N-nitrosodimethylamine (NDMA) in ranitidine  using the Thermo Scientific™ Q Exactive™ Focus hybrid  quadrupole-Orbitrap MS.

Following the March 2019 discovery of genotoxic impurities, N-nitrosodimethylamine and N-nitrosodiethylamine contained in the API of valsartan, it was found that the content of N-Nitroso-N-methyl-4-aminobutyric acid in the hypotensor of losartan potassium exceeded the standard. In August 2019, the FDA extended its investigation into impurities in generic drugs and found that a ranitidine drug also contained N-nitrosodimethylamine impurities. In September 2019, the Food and Drug Administration (FDA) released a detection method for N-nitrosodimethylamine in ranitidine. The European Union subsequently issued a document to extend the assessment of N-nitrosodimethylamine to all chemical synthetic drugs. In just a few months, the supervisory laws and regulations have not only expanded the range of nitrosamine testing items, but are also covering all kinds of chemical drugs.

As a common type of genotoxic impurity nitrosamine compound, N-nitrosodimethylamine (abbreviation: NDMA) can directly or indirectly damage cellular DNA, producing mutagenic and carcinogenic substances. This paper presents a highly sensitive detection method for the analysis of N-nitrosodimethylamine (NDMA) in ranitidine using the Thermo Scientific™ Q Exactive™ Focus hybrid quadrupole-Orbitrap MS. The detection and quantitative limits fully meet FDA requirements. This method can effectively separate the main components of ranitidine and NDMA, and permit NMDA detection with high sensitivity and reproducibility. This method is also the preferred method recommended by the FDA.

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