|
About the Limits of Nitrosamines category
|
|
0
|
1042
|
April 14, 2021
|
|
EMA - Appendix 1 - Update
|
|
77
|
7653
|
March 25, 2026
|
|
N-Nitrosoatorvastatin and applicable potency category 4 or 5
|
|
2
|
79
|
March 20, 2026
|
|
Request for analytical method support – N-nitroso-piperidine in LVP elastomeric packaging (E&L study)
|
|
0
|
80
|
March 19, 2026
|
|
MEGLUMINE (Methylglucamine)
|
|
28
|
3581
|
March 16, 2026
|
|
EMA Q&A Appendix 1 update posted on 13 March 2026
|
|
1
|
317
|
March 16, 2026
|
|
EMA's Revision of the Acceptance Limit for N-Nitroso-N-desmethyl-diphenhydramine
|
|
1
|
276
|
February 27, 2026
|
|
Calculation of Maximum Daily Dose (MDD) for 2 Strengths
|
|
5
|
272
|
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
|
|
1
|
214
|
February 5, 2026
|
|
Nitrosamine control in Metformin /Vildagliptin DP
|
|
6
|
342
|
February 3, 2026
|
|
TGA updated Established acceptable intake for nitrosamines in medicines on 29 January 2026
|
|
0
|
361
|
January 29, 2026
|
|
Nitrosamine Drug Substance-Related Impurities cause DNA methylation adducts in vitro and in primary hepatocytes upon Cytochrome P450-dependend metabolic activation-Pub
|
|
2
|
230
|
January 29, 2026
|
|
Approach for N-Nitroso Imatinib Limits: Database vs ICH S9
|
|
5
|
187
|
January 22, 2026
|
|
EMA has updated its AI limits on 01 Aug 2025
|
|
18
|
2915
|
January 21, 2026
|
|
N-nitroso-Impurity C in Metamizol Drug product
|
|
28
|
2952
|
January 21, 2026
|
|
Limit of Common or Small Nitrosamine Impurities in RSM irrespective of any particular MDD
|
|
9
|
306
|
January 21, 2026
|
|
How to determine the AI limit value and LOQ when MDD is less than 880mg?
|
|
1
|
163
|
January 20, 2026
|
|
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
|
|
14
|
677
|
January 13, 2026
|
|
Detecting Nitrosamines & Mutagenic Impurities
|
|
0
|
210
|
January 12, 2026
|
|
How to Establish MDD for Creams and Ophthalmic Solutions
|
|
4
|
336
|
January 8, 2026
|
|
Nitrosamine Impurities in Excipients
|
|
11
|
516
|
January 8, 2026
|
|
Limits more than one Nitrosamine?
|
|
45
|
3318
|
December 30, 2025
|
|
N-nitrosamides, N-nitrosoureas, Nnitrosoguanidines
|
|
7
|
510
|
December 30, 2025
|
|
Establishing Best Practice for N-Nitrosamine Read-Across and Surrogate Selection
|
|
0
|
247
|
December 22, 2025
|
|
N-Nitroso vonoprazan
|
|
1
|
261
|
December 15, 2025
|
|
Nitrites in Excipients
|
|
7
|
476
|
November 28, 2025
|
|
Grenzwert für N-nitroso oxymetazoline
|
|
4
|
127
|
November 19, 2025
|
|
N-Nitroso-API calculation limit
|
|
9
|
810
|
November 13, 2025
|
|
:australia: TGA - Latest Update to Nitrosamine Limits
|
|
10
|
2386
|
November 3, 2025
|
|
N-Nitroso Sertraline
|
|
9
|
951
|
October 23, 2025
|