|
About the Limits of Nitrosamines category
|
|
0
|
987
|
April 14, 2021
|
|
N-Nitroso-API calculation limit
|
|
8
|
412
|
September 30, 2025
|
|
LTL Approach for New Generic Registrations
|
|
3
|
234
|
September 26, 2025
|
|
Nitrosamines without published AI, and possibly negative for carcinogenicity
|
|
10
|
1118
|
September 25, 2025
|
|
EMA has updated its AI limits on 01 Aug 2025
|
|
16
|
1589
|
September 23, 2025
|
|
Estimation of genotoxic nitroso amines impurities in empagliflozin
|
|
2
|
230
|
September 15, 2025
|
|
Alignment between Regulatory Agencies
|
|
2
|
332
|
September 12, 2025
|
|
Ask for help with limit for Nitroso-olaparib
|
|
2
|
137
|
September 4, 2025
|
|
N-nitroso-omadacycline mutagenic
|
|
3
|
105
|
September 2, 2025
|
|
Why EMA has done read-across for N-nitroso-desmethyl-doxylamine?
|
|
9
|
269
|
September 1, 2025
|
|
Why do nitrosamine impurities of omacycline and tigecycline have different AI values?
|
|
8
|
317
|
August 28, 2025
|
|
N-nitroso-Impurity C in Metamizol Drug product
|
|
27
|
2462
|
August 22, 2025
|
|
Published limit for N-Nitroso-Vonoprazan
|
|
2
|
247
|
August 15, 2025
|
|
:australia: TGA - Latest Update to Nitrosamine Limits
|
|
9
|
2014
|
July 31, 2025
|
|
N-nitroso-amlodipine ; N-nitroso-felodipine ; synthesis not successfull but still listed by FDA and EMA as NDSRIs
|
|
15
|
4472
|
April 16, 2025
|
|
Lifetime Cumulative Dose and Less Than Lifetime Approach
|
|
3
|
533
|
July 16, 2025
|
|
MEGLUMINE (Methylglucamine)
|
|
27
|
3191
|
July 10, 2025
|
|
Criterios de aceptación
|
|
2
|
91
|
June 26, 2025
|
|
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
|
|
10
|
490
|
June 26, 2025
|
|
Limits more than one Nitrosamine?
|
|
44
|
2775
|
June 26, 2025
|
|
Quantifier and Qualifier Ion in mass spec
|
|
6
|
200
|
June 26, 2025
|
|
Calculation of limit when more than one nitrosamine is identified
|
|
10
|
1198
|
June 19, 2025
|
|
Risk (Re)Assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine Drug Substance Related Impurities
|
|
2
|
204
|
June 18, 2025
|
|
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
|
|
0
|
203
|
June 6, 2025
|
|
AI limit for 1-Nitrosopiperazine
|
|
8
|
402
|
June 4, 2025
|
|
EMA - Appendix 1 - Update
|
|
57
|
5599
|
May 30, 2025
|
|
Limits for NDMA in Dapagliflozin+Metformin
|
|
19
|
466
|
May 28, 2025
|
|
If only I had known…
|
|
41
|
2031
|
May 23, 2025
|
|
How to set Acceptance criteria for nitrosamines impurities in FDC-FPPs
|
|
1
|
179
|
May 6, 2025
|
|
MDD for Metformin
|
|
4
|
263
|
May 2, 2025
|