|
Limit of Common or Small Nitrosamine Impurities in RSM irrespective of any particular MDD
|
|
9
|
412
|
January 21, 2026
|
|
How to determine the AI limit value and LOQ when MDD is less than 880mg?
|
|
1
|
203
|
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
|
863
|
January 13, 2026
|
|
Detecting Nitrosamines & Mutagenic Impurities
|
|
0
|
235
|
January 12, 2026
|
|
How to Establish MDD for Creams and Ophthalmic Solutions
|
|
4
|
397
|
January 8, 2026
|
|
Nitrosamine Impurities in Excipients
|
|
11
|
595
|
January 8, 2026
|
|
Limits more than one Nitrosamine?
|
|
45
|
3604
|
December 30, 2025
|
|
N-nitrosamides, N-nitrosoureas, Nnitrosoguanidines
|
|
7
|
616
|
December 30, 2025
|
|
Establishing Best Practice for N-Nitrosamine Read-Across and Surrogate Selection
|
|
0
|
261
|
December 22, 2025
|
|
N-Nitroso vonoprazan
|
|
1
|
354
|
December 15, 2025
|
|
Nitrites in Excipients
|
|
7
|
571
|
November 28, 2025
|
|
Grenzwert für N-nitroso oxymetazoline
|
|
4
|
148
|
November 19, 2025
|
|
N-Nitroso-API calculation limit
|
|
9
|
949
|
November 13, 2025
|
|
:australia: TGA - Latest Update to Nitrosamine Limits
|
|
10
|
2552
|
November 3, 2025
|
|
N-Nitroso Sertraline
|
|
9
|
1085
|
October 23, 2025
|
|
N-Nitroso mirabegron
|
|
7
|
2799
|
October 15, 2025
|
|
Help/Information needed: Are bis-Aryl-Azoxy-compounds CoC or not?
|
|
3
|
198
|
October 13, 2025
|
|
LTL Approach for New Generic Registrations
|
|
5
|
596
|
October 10, 2025
|
|
Nitrosamines without published AI, and possibly negative for carcinogenicity
|
|
11
|
1397
|
October 7, 2025
|
|
Estimation of genotoxic nitroso amines impurities in empagliflozin
|
|
2
|
328
|
September 15, 2025
|
|
Alignment between Regulatory Agencies
|
|
2
|
510
|
September 12, 2025
|
|
Ask for help with limit for Nitroso-olaparib
|
|
2
|
349
|
September 4, 2025
|
|
N-nitroso-omadacycline mutagenic
|
|
3
|
182
|
September 2, 2025
|
|
Why EMA has done read-across for N-nitroso-desmethyl-doxylamine?
|
|
9
|
486
|
September 1, 2025
|
|
Why do nitrosamine impurities of omacycline and tigecycline have different AI values?
|
|
8
|
453
|
August 28, 2025
|
|
N-nitroso-amlodipine ; N-nitroso-felodipine ; synthesis not successfull but still listed by FDA and EMA as NDSRIs
|
|
15
|
4970
|
April 16, 2025
|
|
Lifetime Cumulative Dose and Less Than Lifetime Approach
|
|
3
|
634
|
July 16, 2025
|
|
Criterios de aceptación
|
|
2
|
151
|
June 26, 2025
|
|
Quantifier and Qualifier Ion in mass spec
|
|
6
|
403
|
June 26, 2025
|
|
Calculation of limit when more than one nitrosamine is identified
|
|
10
|
1402
|
June 19, 2025
|