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About the Limits of Nitrosamines category
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0
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1037
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April 14, 2021
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Calculation of Maximum Daily Dose (MDD) for 2 Strengths
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5
|
128
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February 17, 2026
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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-Pub
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1
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181
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February 5, 2026
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Nitrosamine control in Metformin /Vildagliptin DP
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6
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315
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February 3, 2026
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TGA updated Established acceptable intake for nitrosamines in medicines on 29 January 2026
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0
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335
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January 29, 2026
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Nitrosamine Drug Substance-Related Impurities cause DNA methylation adducts in vitro and in primary hepatocytes upon Cytochrome P450-dependend metabolic activation-Pub
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2
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216
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January 29, 2026
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Approach for N-Nitroso Imatinib Limits: Database vs ICH S9
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5
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175
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January 22, 2026
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EMA has updated its AI limits on 01 Aug 2025
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18
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2769
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January 21, 2026
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N-nitroso-Impurity C in Metamizol Drug product
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28
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2879
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January 21, 2026
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Limit of Common or Small Nitrosamine Impurities in RSM irrespective of any particular MDD
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9
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290
|
January 21, 2026
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How to determine the AI limit value and LOQ when MDD is less than 880mg?
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1
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154
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January 20, 2026
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Deriving safe limits for N-nitroso-bisoprolol by error-corrected next-generation sequencing (ecNGS) and benchmark dose (BMD) analysis, integrated with QM modeling and CYP-docking analysis
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14
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655
|
January 13, 2026
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Detecting Nitrosamines & Mutagenic Impurities
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0
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201
|
January 12, 2026
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How to Establish MDD for Creams and Ophthalmic Solutions
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4
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325
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January 8, 2026
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Nitrosamine Impurities in Excipients
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11
|
497
|
January 8, 2026
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Limits more than one Nitrosamine?
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45
|
3276
|
December 30, 2025
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N-nitrosamides, N-nitrosoureas, Nnitrosoguanidines
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7
|
498
|
December 30, 2025
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Establishing Best Practice for N-Nitrosamine Read-Across and Surrogate Selection
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0
|
240
|
December 22, 2025
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N-Nitroso vonoprazan
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1
|
236
|
December 15, 2025
|
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EMA - Appendix 1 - Update
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70
|
7206
|
December 5, 2025
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Nitrites in Excipients
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7
|
460
|
November 28, 2025
|
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Grenzwert für N-nitroso oxymetazoline
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4
|
123
|
November 19, 2025
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N-Nitroso-API calculation limit
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9
|
786
|
November 13, 2025
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:australia: TGA - Latest Update to Nitrosamine Limits
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10
|
2358
|
November 3, 2025
|
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N-Nitroso Sertraline
|
|
9
|
925
|
October 23, 2025
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N-Nitroso mirabegron
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7
|
2723
|
October 15, 2025
|
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Help/Information needed: Are bis-Aryl-Azoxy-compounds CoC or not?
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3
|
175
|
October 13, 2025
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LTL Approach for New Generic Registrations
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5
|
461
|
October 10, 2025
|
|
Nitrosamines without published AI, and possibly negative for carcinogenicity
|
|
11
|
1310
|
October 7, 2025
|
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Estimation of genotoxic nitroso amines impurities in empagliflozin
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2
|
275
|
September 15, 2025
|