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) |