Skip to main content
. 2022 Dec 24;31(2):295–311. doi: 10.1016/j.jsps.2022.12.010

Table 1.

Summary of the main focus of previous review articles on nitrosamine contamination.

Year of Publication Title Main focus Ref.
2019 Short commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products Specific review of NDMA contamination in valsartan products Snodin and Elder (2019)
2020 Nitrosamine impurities in drug substances and drug products Review of nitrosamine cross-contamination possibilities to pharmaceuticals, limits and acceptable intake of NDMA and NDEA in sartans and published analytical techniques. Shaikh et al. (2020)
2020 Regulatory updates and analytical methodologies for nitrosamine impurities detection in sartans, ranitidine, nizatidine, and metformin along with sample preparation techniques Basic principles and recently updated information on methods and sample preparation for nitrosamine analysis. Shaik et al. (2020)
2020 Pathways for N-nitroso compound formation: Secondary amines and beyond The reaction conditions and reactant leading to N-nitroso compound formations. López-Rodriguez et al. (2020)
2021 Nitrosamine contamination in pharmaceuticals: Threat, Impact, and Control The source of nitrosamine contamination in pharmaceuticals such as sartans, ranitidine and nizatidine. Discuss the methodologies for trace nitrosamine analyses, risk assessment-based approach and control measures. Tuesuwan and Vongsutilers (2021)
2021 N-nitrosodimethylamine (NDMA) contamination of Ranitidine Products: A review of recent findings Specific observation of ranitidine degradation to NDMA Aldawsari et al. (2021)
2021 Presence of nitrosamine impurities in medicinal products Short communication of the EU regulatory response and the Croatian market situation on NDMA and NDEA contamination events in pharmaceutical products Sedlo et al. (2021)
2021 Critical analysis of drug product recalls due to nitrosamine impurities. Case reports and risk analysis of drug product recalls due to the nitrosamine impurities Bharate (2021)
2021 An organic chemist’s guide to N-nitrosamines: Their structure, reactivity, and role as contaminants The perspective on the chemical structure, reactivity, and synthetic applications of alkyl N-nitrosamines Beard and Swager (2021)
2021 Nitrosamine reactivity: A survey of reactions and purge processes. The development of effective chemical processes for the control of nitrosamine contamination. Borths et al. (2021)
2022 A review of nitrosamine impurities present in drugs Short report the contamination events in pharmaceuticals and control measures from the global regulatory agencies such as EMA, CHMP, USFDA Dattatraya et al. (2022)