Absolute Quantitation of N-Nitrosamines by Coulometric Mass Spectrometry without Using Standards

Author:

Wang Qi1ORCID,Liu Zhijian2,Liu Yong3,Chen Hao1ORCID

Affiliation:

1. Department of Chemistry and Environmental Science, New Jersey Institute of Technology, Newark, New Jersey 07102, United States

2. Department of Process Research and Development, Merck Research Laboratories, Merck & Co., Inc., Rahway, New Jersey 07065, United States

3. Analytical Research and Development, Merck Research Laboratories, Merck & Co., Inc., Rahway, New Jersey 07065, United States

Funder

National Institute of General Medical Sciences

Publisher

American Chemical Society (ACS)

Subject

Spectroscopy,Structural Biology

Reference40 articles.

1. Inhibition of N-Nitrosamine Formation in Drug Products: A Model Study

2. Potential for the Formation of N-Nitrosamines during the Manufacture of Active Pharmaceutical Ingredients: An Assessment of the Risk Posed by Trace Nitrite in Water

3. An Organic Chemist’s Guide to N-Nitrosamines: Their Structure, Reactivity, and Role as Contaminants

4. International Agency for Research on Cancer (IARC). List of Classifications, Agents classified by the IARC Monograph, Vol. 1−131, https://monographs.iarc.who.int/list-of-classifications (accessed 8 April 2022).

5. European Medicines Agency. In ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. 2015; Vol. EMA/CHMP/ICH/83812/2013;https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-assessment-control-dna-reactivemutagenic-impurities-pharmaceuticals-limitpotential_en.pdf (accessed 25 August 2015).

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