Current - Issue

1) Dobariya U, Chauhan N, Patel H, Pardeshi N. Nitrosamine Impurities: Origin, Control and Regulatory Recommendations. International
Journal of Drug Regulatory Affairs. 2021;9(2):77-80.
2) Manchuri KM, Kuril AK, Shaik MA, Gopireddy VS, Sultana N. An update on latest regulatory guidelines and analytical methodologies
for N-nitrosamine impurities in pharmaceutical products–2024. Medical Gas Research. 2025 Apr 29;15(4):535.
3) Tummala SR, Amgoth KP. Development of GC-MS/MS method for simultaneous estimation of four nitrosoamine genotoxic impurities
in Valsartan. Turkish Journal of Pharmaceutical Sciences. 2022 Aug 31;19(4):455.
4) Manchuri KM, Shaik MA, Gopireddy VS, Gogineni S. Analytical Methodologies to Detect N-Nitrosamine Impurities in Active
Pharmaceutical Ingredients, Drug Products and Other Matrices. Chemical Research in Toxicology. 2024 Sep 16;37(9):1456-83.
5) Thomas DN, Wills JW, Burman M, Williams AN, Harte DS, Buckley RA, Urquhart MW, Bretonnet AS, Jeffries B, White AT, Harvey
JS. Resolution of historically discordant Ames test negative/rodent carcinogenicity positive N-nitrosamines using a sensitive, OECD-
aligned design. Mutagenesis. 2025 Apr;40(2):116-25.
6) Ping Y, Liu Y, Wen H, Wen N, Li B, Chen Y, Tian Y. Determination of nitrite in rifapentine and analysis of the formation causes of
nitrosamine impurity. Front Chem. 2026;14:1791665. doi:10.3389/fchem.2026.1791665.
7) Shaik RB, Padala SKR, Gupta M, Devi DR, Basavaiah K, Rao BM. Structural and in silico safety evaluation of asciminib degradation
products with a validated stability indicating HPLC method for genotoxic impurity determination. Sci Rep. 2026;16:14965.
doi:10.1038/s41598-026-44693-0.
8) Adamson RH, Chabner BA. The finding of N-nitrosodimethylamine in common medicines. Toxicol Pathol. 2020.
9) Salim H, Jones AM. Angiotensin II receptor blockers (ARBs) and manufacturing contamination: A retrospective National Register Study
into suspected associated adverse drug reactions. Br J Clin Pharmacol. 2022;88:4812-4827. doi:10.1111/bcp.15411.
10) Regulska K, Musiał J, Stanisz BJ. Solid-State Stability Profiling of Ramipril to Optimize Its Quality Efficiency and Safety. Pharmaceutics.2021;13:1600. doi:10.3390/pharmaceutics13101600.
11) Järvholm B, Lavenius B, Sällsten G. Cancer morbidity in workers exposed to cutting fluids containing nitrites and amines. Br J Ind Med.
1986;43:563-565.
12) Bolleddula J, Gopalakrishnan S, Hu P, Dong J, Venkatakrishnan K. Alternatives to rifampicin: a review and perspectives on the choice of
strong CYP3A inducers for clinical drug–drug interaction studies. Clinical and Translational Science. 2022 Sep;15(9):2075-95.
13) Vogel M, Escher SE, Weiler E, Londenberg A, Deppenmeier U, Whomsley R. Quantitative Investigation of Nitrosamine Drug Substance‐
Related Impurities (NDSRIs) Under Artificial Gastric Conditions by Liquid Chromatography–Tandem Mass Spectrometry and Structure–
Activity Relationship Analysis. Drug Testing and Analysis. 2025 Sep;17(9):1772-84.
14) Shomali F, Talebpour Z, Abedi G, Mousavi N, Mokhtarifar S, Kohandani M, Mahdavi V, Adib N. Analysis and risk assessment of
nitrosamines in sartans using GC-MS and Monte Carlo simulation. Scientific Reports. 2025 Jun 6;15(1):20032.
15) Sana B, Nedjoud G, Sihem K, Hadia H, Aslam AA, Mughram MH, Alzahrani KJ, Irfan M, Ahmed M. N‐Nitrosodimethylamine as an
Emerging Environmental Contaminant: Sources, Analytical Advances, and Ecotoxicological and Human Health Risks. International
Journal of Analytical Chemistry. 2026;2026(1):1536227.
16) Hassanin HA, Hannibal L, Jacobsen DW, El-Shahat MF, Hamza MS, Brasch NE. Mechanistic studies on the reaction between R2N-
NONOates and aquacobalamin: evidence for direct transfer of a nitroxyl group from R2N-NONOates to cobalt (III) centers. Angewandte
Chemie (International ed. in English). 2009;48(47):8909.
17) Dittberner U, Eisenbrand G, Zankl H. Cytogenetic effects of N-nitrosodiethanolamine (NDELA) and NDELA-monoacetate in human
lymphocytes. J Cancer Res Clin Oncol. 1988;114:575-578.
18) Beard JC, Swager TM. An organic chemist’s guide to N-nitrosamines: their structure, reactivity, and role as contaminants. The Journal of
organic chemistry. 2021 Jan 21;86(3):2037.
19) Knasmüller S, Stehlik G, Mohn G. Studies on the metabolic activation of diethanolnitrosamine in animal-mediated and in vitro assays
using Escherichia coli K-12 343/113 as an indicator. J Cancer Res Clin Oncol. 1986;112:266-271.
20) Monarca S, Scassellati Sforzolini G, Spiegelhalder B, Pasquini R, Fatigoni C. Monitoring nitrite, N-nitrosodiethanolamine, and
mutagenicity in cutting fluids used in the metal industry. Environ Health Perspect. 1993;101:126-128.
21) Knasmüller S, Stehlik G, Mohn G. Studies on the metabolic activation of diethanolnitrosamine in animal-mediated and in vitro assays
using Escherichia coli K-12 343/113 as an indicator. Journal of cancer research and clinical oncology. 1986 Nov;112(3):266-71.
22) Monarca S, Scassellati-Sforzolini G, Donato F, Angeli G, Spiegelhalder B, Pasquini R. Biological monitoring of workers exposed to N-
nitrosodiethanolamine in the metal industry.
23) Lee SH, Kim HY. Effect of sodium nitrite, sodium chloride and concentrated seawater on physicochemical properties of meat emulsion
system. Food Sci Anim Resour. 2020;40(6):980-989. doi:10.5851/kosfa.2020.e68.
24) Xu N, Goodrich LE, Lehnert N, Powell DR, Richter-Addo GB. Five-and six-coordinate adducts of nitrosamines with ferric porphyrins:
structural models for the type II interactions of nitrosamines with ferric cytochrome P450. Inorganic chemistry. 2010 May 17;49(10):4405.
25) Cha KH, Wang X, Meyerhoff ME. Nitric Oxide Release for Improving Performance of Implantable Chemical Sensors – A Review. Appl
Mater Today. 2017;9:589-597. doi:10.1016/j.apmt.2017.10.002.
26) Giménez-Campillo C, Pastor-Belda M, Campillo N, Hernández JD, Guillén I, Vizcaíno P, López-García I, Hernández-Córdoba M, Arroyo-
Manzanares N, Viñas P. Ultrasound assisted extraction approach to test the effect of elastic rubber nettings on the N-nitrosamines content
of Ham meat samples. Foods. 2021 Oct 24;10(11):2564.
27) Piknova B, Schechter AN. Measurement of Nitrite in Blood Samples Using the Ferricyanide-Based Hemoglobin Oxidation Assay.
Methods Mol Biol. 2011;704:39-56. doi:10.1007/978-1-61737-964-2_4.
28) EFSA Panel on Contaminants in the Food Chain (EFSA CONTAM Panel), Schrenk D, Bignami M, Bodin L, Chipman JK, del Mazo J,
Hogstrand C, Hoogenboom L, Leblanc JC, Nebbia CS, Nielsen E. Risk assessment of N‐nitrosamines in food. Efsa Journal. 2023
Mar;21(3):e07884.
29) EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), Mortensen A, Aguilar F, Crebelli R, Di Domenico A,
Dusemund B, Frutos MJ, Galtier P, Gott D, Gundert‐Remy U, Lambré C. Re‐evaluation of potassium nitrite (E 249) and sodium nitrite
(E 250) as food additives. Efsa journal. 2017 Jun;15(6):e04786.
30) Tabish TA, Hussain MZ, Zervou S, Myers WK, Tu W, Xu J, et al. S-nitrosocysteamine-functionalised porous graphene oxide nanosheets
as nitric oxide delivery vehicles for cardiovascular applications. Redox Biol. 2024;72:103144. doi:10.1016/j.redox.2024.103144.
31) Cha KH, Wang X, Meyerhoff ME. Nitric Oxide Release for Improving Performance of Implantable Chemical Sensors – A Review. Appl
Mater Today. 2017;9:589-597. doi:10.1016/j.apmt.2017.10.002.
32) Vogel M, Escher SE, Weiler E, Londenberg A, Deppenmeier U, Whomsley R. Quantitative Investigation of Nitrosamine Drug Substance‐
Related Impurities (NDSRIs) Under Artificial Gastric Conditions by Liquid Chromatography–Tandem Mass Spectrometry and Structure–
Activity Relationship Analysis. Drug Testing and Analysis. 2025 Sep;17(9):1772-84.
33) Yalamanchili J, Himavathi G, Suresh S. A Rapid and Sensitive LC–MS/MS Method for Quantification of NDSRI in Melatonin Drug
Product via Controlled In Situ Formation. Biomedical Chromatography. 2026 Oct;40(10):e70591.
34) Zhao C, Xia Y, Shi Q, Gu Y, Zhang L, Dong R, Zhang Y, Han S, Jiang Y, Xiong W, Guo H. Mediation of sphingolipid metabolism on
the relationship between human nitrosamines exposure and esophageal cancer risk. Scientific Reports. 2026 Apr 13.
35) Nardin T, Franceschini J, Martinelli F, Franciosi E, Larcher R. Comprehensive Assessment of nitrosamine formation in meat products
using UHPLC-HRMS: analytical challenges and potential dietary implications. Molecules. 2025 Oct 16;30(20):4107.
36) Heflich RH, Bishop ME, Mittelstaedt RA, Yan J, Guerrero SK, Sims AM, Mitchell K, Moore N, Li X, Mei N, Elespuru RK. Optimizing
the detection of N-nitrosamine mutagenicity in the Ames test. Regulatory Toxicology and Pharmacology. 2024 Nov 1;153:105709.
37) Bondonno CP, Sundqvist ML, Shinde S, Croft K, Hodgson JM, Carlström M, et al. A clinical study examining the effects of dietary nitrate
on urinary N-nitrosamines. Am J Clin Nutr. 2026;123:101239. doi:10.1016/j.ajcnut.2026.101239.
38) Thomas R, Tennant RE, Oliveira AA, Ponting DJ. What makes a potent nitrosamine? Statistical validation of expert-derived structure–
activity relationships. Chemical research in toxicology. 2022 Oct 27;35(11):1997.
39) Sallan S, Yılmaz Oral ZF, Kaya M. A Review on the Role of Lactic Acid Bacteria in the Formation and Reduction of Volatile Nitrosamines
in Fermented Sausages. Foods. 2023;12:702. doi:10.3390/foods12040702.
40) Brender JD, Werler MM, Shinde MU, Vuong AM, Kelley KE, Huber JC Jr, et al. Nitrosatable drug exposure during the first trimester of
pregnancy and selected congenital malformations. Birth Defects Res A Clin Mol Teratol. 2012;94(9):701-713. doi:10.1002/bdra.23060.
41) EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). Re-evaluation of potassium nitrite (E 249) and sodium nitrite(E 250) as food additives. EFSA Journal. 2017;15(6):4786. doi:10.2903/j.efsa.2017.4786.
42) Sana B, Grara N, Khadri S, Hemmami H, Aslam AA, AL Mughram MH, et al. N-Nitrosodimethylamine as an Emerging Environmental
Contaminant: Sources, Analytical Advances, and Ecotoxicological and Human Health Risks. Int J Anal Chem. 2026;2026:1536227.
doi:10.1155/ianc/1536227.
43) Tabish TA, Hussain MZ, Zervou S, Myers WK, Tu W, Xu J, et al. S-nitrosocysteamine-functionalised porous graphene oxide nanosheets
as nitric oxide delivery vehicles for cardiovascular applications. Redox Biol. 2024;72:103144. [Duplicate of uploaded article 30].
44) Knasmüller S, Stehlik G, Mohn G. Studies on the metabolic activation of diethanolnitrosamine in animal-mediated and in vitro assays
using Escherichia coli K-12 343/113 as an indicator. J Cancer Res Clin Oncol. 1986;112:266-271.
45) de Jong S, Nosal DG, Wardrop DJ. Methods for direct alkene diamination, new & old. Tetrahedron. 2012;68(22):4067-4105.
doi:10.1016/j.tet.2012.03.036.
46) Gankhuyag N, Lee KH, Cho JY. The Role of Nitrosamine (NNK) in Breast Cancer Carcinogenesis. J Mammary Gland Biol Neoplasia.
2017;22:159-170. doi:10.1007/s10911-017-9381-z.
47) Darvishmotevalli M, Moradnia M, Noorisepehr M, Fatehizadeh A, Fadaei S, Mohammadi H, et al. Evaluation of carcinogenic risks related
to nitrate exposure in drinking water in Iran. MethodsX. 2019;6:1716-1727. doi:10.1016/j.mex.2019.07.008.
48) Huber JC Jr, Brender JD, Zheng Q, Sharkey JR, Vuong AM, Shinde MU, et al. Maternal dietary intake of nitrates, nitrites and nitrosamines
and selected birth defects in offspring: a case-control study. Environ Health. [Publication details as provided in uploaded article].
49) Perlman DH, Bauer SM, Ashrafian H, Bryan NS, Garcia-Saura MF, Lim CC, et al. Mechanistic Insights into Nitrite-Induced
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doi:10.1161/CIRCRESAHA.108.187005.