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Nitrosamine Impurities: The Analytical & Regulatory Roadmap (2024-2025)
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0
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490
|
January 20, 2026
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N-nitrosamides, N-nitrosoureas, Nnitrosoguanidines
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7
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713
|
December 30, 2025
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Establishing Best Practice for N- Nitrosamine Read-Across and Surrogate Selection
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0
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194
|
December 22, 2025
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N-Nitroso vonoprazan
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1
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408
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December 15, 2025
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Nitrosamines in macrocyclic antibiotics
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2
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306
|
December 10, 2025
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Issue with Area Drop During N-Nitroso Dorzolamide Method Setup
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3
|
269
|
December 10, 2025
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NDSRI in Pyrathiazine theocolate
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3
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383
|
December 5, 2025
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WHO Updates on Nitrosamine Impurities
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3
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805
|
December 3, 2025
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FDA Approves Reformulated Ranitidine - Nitrosamine Impurities - NDMA
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3
|
661
|
November 27, 2025
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๐ก-๐ก๐ถ๐๐ฟ๐ผ๐๐ฎ๐บ๐ถ๐ป๐ฒ ๐๐ผ๐ฟ๐บ๐ฎ๐๐ถ๐ผ๐ป ๐ถ๐ป ๐ฃ๐ต๐ฎ๐ฟ๐บ๐ฎ๐ฐ๐ฒ๐๐๐ถ๐ฐ๐ฎ๐น ๐๐ฟ๐๐ด ๐ฃ๐ฟ๐ผ๐ฑ๐๐ฐ๐๐: ๐๐ฒ๐๐ฒ๐น๐ผ๐ฝ๐บ๐ฒ๐ป๐ ๐ฎ๐ป๐ฑ ๐ฉ๐ฎ๐น๐ถ๐ฑ๐ฎ๐๐ถ๐ผ๐ป ๐ผ๐ณ ๐ฎ ๐๐ถ๐ฎ๐๐ฒ๐ฑ, ๐๐ผ๐ป๐๐ฒ๐ฟ๐๐ฎ๐๐ถ๐๐ฒ, ๐ฃ๐ฟ๐ฒ๐ฑ๐ถ๐ฐ๐๐ถ๐๐ฒ ๐ ๐ผ๐ฑ๐ฒ๐น
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1
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380
|
November 26, 2025
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N-Nitrosamine Formation in Pharmaceutical Drug Products: Development and Validation of a Biased, Conservative, Predictive Model-Pub
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4
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615
|
November 24, 2025
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Studies addressing potential bioactivation and genotoxicity liabilities of the N-nitroso derivative of the antidepressant paroxetine-Pub
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0
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132
|
November 18, 2025
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N-Nitroso Sertraline
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9
|
1168
|
October 23, 2025
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Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
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18
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5570
|
September 20, 2025
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Nitrosamines risk in cleaning validation approach
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11
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535
|
September 4, 2025
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Ask for help with limit for Nitroso-olaparib
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2
|
427
|
September 4, 2025
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๐จโ๐ป Quantitative Analysis of NDMA, N-Nitroso-l-ephedrine and N-Nitroso-pseudoephedrine in Pseudoephedrine Hydrochloride by HPLC-Tandem MS
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2
|
832
|
August 28, 2025
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Three-Pronged Approach (Active Pharmaceutical Ingredients, Excipients, and NOx-Free Air) Successfully Suppressed the Formation of Nitroso-atomoxetine to 0.097 ppm
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0
|
557
|
August 24, 2025
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Primary amines in formation of nitrosamine
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6
|
1390
|
August 13, 2025
|
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Nitrosamine Risk Mitigation Calculator (by DFE Pharma)
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1
|
1692
|
August 11, 2025
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๐บ๐ธ FDA - Fiscal Year 2024 Generic Drug Science and Research Initatives Public Workshop
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19
|
2387
|
August 7, 2025
|
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Highlights from the 13th meeting of the Nitrosamine Implementation Oversight Group (NIOG)
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7
|
643
|
July 22, 2025
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Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cells -Pub
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0
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283
|
July 12, 2025
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CMO Nitrosamine Risk Assessment
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7
|
582
|
June 27, 2025
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Analytical Method Development Strategy for Controlling Two New Nitrosamine Drug Substance Related Impurities (NDSRIs) in a Pharmaceutical Drug Product for Treatment of a Rare Disease -Pub
|
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0
|
166
|
June 25, 2025
|
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Optimizing Pharmaceutical Formulations: Strategies for Improving Stability and Minimizing Nitrosamine Impurities-Webinar
|
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1
|
373
|
June 20, 2025
|
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Using N-Nitrosodiethanolamine (NDELA) and N-Nitrosopiperidine (NPIP) Transgenic Rodent Gene Mutation Data and Quantum Mechanical Modeling to Derive Potency-Based Acceptable Intakes for NDSRIs Lacking Robust Carcinogenicity Data-Pub
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0
|
342
|
June 6, 2025
|
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ยนโตN-Enriched NAP Test
|
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0
|
273
|
May 31, 2025
|
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N-nitroso Torasemide Impurity formation and control
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|
33
|
3234
|
May 27, 2025
|
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Optimizing the detection of N-nitrosamine mutagenicity in the Ames test -Pub
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17
|
933
|
May 23, 2025
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