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References from DNA Damage and Micronucleus Induction by Small‐Molecule Nitrosamine Drug Impurities and Nitrosamine Drug Substance‐Related Impurities in HepaRG Cells. Local targets link to admitted publications; unresolved targets remain external evidence.
Nitrosamine Ames Data Review and Method Development: Proceedings of a US FDA/HESI Workshop
10.1093/mutage/geag011 · 2026 · External reference
HESI GTTC Ring Trial: Concordance Between Ames and Rodent Carcinogenicity Outcomes for N‐Nitrosamines (NAs) With Rat and Hamster Metabolic Conditions
10.1016/j.yrtph.2025.105835 · 2025 · External reference
Formation of N‐Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
10.1021/acs.oprd.3c00153 · 2024 · External reference
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DNA Alkylation Damage by Nitrosamines and Relevant DNA Repair Pathways
10.3390/ijms24054684 · 2023 · External reference
Unresolved reference
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Nitrosamine Acceptable Intakes Should Consider Variation in Molecular Weight: The Implication of Stoichiometric DNA Damage
10.1016/j.yrtph.2023.105505 · 2023 · External reference
Ames Mutagenicity of 15 Aryl, Benzyl, and Aliphatic Ring N‐Nitrosamines
10.1016/j.yrtph.2024.105763 · 2025 · External reference
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External reference
Optimizing the Detection of N‐Nitrosamine Mutagenicity in the Ames Test
10.1016/j.yrtph.2024.105709 · 2024 · External reference
Regulatory Experiences With Root Causes and Risk Factors for Nitrosamine Impurities in Pharmaceuticals
10.1016/j.xphs.2022.12.022 · 2023 · External reference
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Measuring Reproducibility of Dose Response Data for the Pig‐a Assay Using Covariate Benchmark Dose Analysis
10.1016/j.mrgentox.2016.04.004 · 2016 · External reference
Ames Concordance With the In Vivo Transgenic Rodent (TGR) Gene Mutation Assay for NDSRIs and Relative In Vivo TGR Potency With Nitrosamines With Robust Dose‐Response Carcinogenicity Data
10.1016/j.yrtph.2026.106051 · 2026 · External reference
Strong Nasal Carcinogenicity and Genotoxicity of 1‐Nitroso‐4‐Methylpiperazine After Low Dose Inhalation in Rats
10.1093/carcin/20.8.1629 · 1999 · External reference
Determining Recommended Acceptable Intake Limits for N‐Nitrosamine Impurities in Pharmaceuticals: Development and Application of the Carcinogenic Potency Categorization Approach (CPCA)
10.1016/j.yrtph.2024.105640 · 2024 · External reference
Unresolved reference
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Genotoxicity Evaluation of Nitrosamine Impurities Using Human TK6 Cells Transduced With Cytochrome P450s
10.1007/s00204-022-03347-6 · 2022 · External reference
Mutagenicity and Genotoxicity Evaluation of 15 Nitrosamine Drug Substance‐Related Impurities in Human TK6 Cells
10.1016/j.yrtph.2024.105730 · 2024 · External reference
Revisiting the Mutagenicity and Genotoxicity of N‐Nitroso Propranolol in Bacterial and Human In Vitro Assays
10.1016/j.yrtph.2023.105410 · 2023 · External reference
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1984 · External reference
Unresolved reference
2017 · External reference
The Nitrosamine “Saga”: Lessons Learned From Five Years of Scrutiny
10.1021/acs.oprd.3c00100 · 2023 · External reference
10.1787/61eca5cd-en
10.1787/61eca5cd-en · 2017 · External reference
Unresolved reference
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Comparative DNA Damage Induced by Eight Nitrosamines in Primary Human and Macaque Hepatocytes
10.1016/j.cbi.2025.111538 · 2025 · External reference
Evaluation of an In Vitro Three‐Dimensional HepaRG Spheroid Model for Genotoxicity Testing Using the High‐Throughput CometChip Platform
2022 · External reference
High‐Throughput Micronucleus Assay Using Three‐Dimensional HepaRG Spheroids for In Vitro Genotoxicity Testing
10.1007/s00204-023-03461-z · 2023 · External reference
Quantitative Comparison of In Vitro Genotoxicity Between Metabolically Competent HepaRG Cells and HepG2 Cells Using the High‐Throughput High‐Content CometChip Assay
10.1007/s00204-019-02406-9 · 2019 · External reference
Genotoxicity Evaluation of Ten Nitrosamine Drug Substance‐Related Impurities Using 2D and 3D HepaRG Cell Models
10.1016/j.yrtph.2025.105906 · 2025 · External reference
Genotoxicity Assessment of Eight Nitrosamines Using 2D and 3D HepaRG Cell Models
10.1007/s00204-023-03560-x · 2023 · External reference
Bumetanide as a Model NDSRI Substrate: N‐Nitrosobumetanide Impurity Formation and Its Inhibition in Bumetanide Tablets
10.1016/j.xphs.2023.06.013 · 2023 · External reference
Unresolved reference
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N‐Nitroso‐Phenylephrine, a Nitrosamine Drug Substance‐Related Impurity That Is Negative in the Enhanced Ames Test but Mutagenic in HepaRG Cells
2026 · External reference
