About the Limits of Nitrosamines category
|
|
0
|
969
|
April 14, 2021
|
N-nitroso-amlodipine ; N-nitroso-felodipine ; synthesis not successfull but still listed by FDA and EMA as NDSRIs
|
|
15
|
4217
|
April 16, 2025
|
Lifetime Cumulative Dose and Less Than Lifetime Approach
|
|
3
|
409
|
July 16, 2025
|
MEGLUMINE (Methylglucamine)
|
|
27
|
3012
|
July 10, 2025
|
Criterios de aceptación
|
|
2
|
82
|
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
|
439
|
June 26, 2025
|
Limits more than one Nitrosamine?
|
|
44
|
2636
|
June 26, 2025
|
Quantifier and Qualifier Ion in mass spec
|
|
6
|
158
|
June 26, 2025
|
Calculation of limit when more than one nitrosamine is identified
|
|
10
|
1148
|
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
|
195
|
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
|
193
|
June 6, 2025
|
AI limit for 1-Nitrosopiperazine
|
|
8
|
318
|
June 4, 2025
|
EMA - Appendix 1 - Update
|
|
57
|
5267
|
May 30, 2025
|
Limits for NDMA in Dapagliflozin+Metformin
|
|
19
|
411
|
May 28, 2025
|
If only I had known…
|
|
41
|
1983
|
May 23, 2025
|
How to set Acceptance criteria for nitrosamines impurities in FDC-FPPs
|
|
1
|
156
|
May 6, 2025
|
N-nitroso-Impurity C in Metamizol Drug product
|
|
16
|
1947
|
May 6, 2025
|
MDD for Metformin
|
|
4
|
241
|
May 2, 2025
|
:australia: TGA - Latest Update to Nitrosamine Limits
|
|
8
|
1781
|
May 2, 2025
|
Risk Assessment ASS/Paracetamol/Coffein tablets
|
|
7
|
566
|
April 29, 2025
|
Visualization of Categorized Compounds by CPCA
|
|
67
|
8579
|
April 24, 2025
|
N-nitroso-esmolol
|
|
0
|
109
|
April 22, 2025
|
⁉️ Duloxetine Impurity NDSRI
|
|
9
|
923
|
April 22, 2025
|
The quagmire with the interim limit of nitroso duloxetine
|
|
6
|
554
|
April 21, 2025
|
LTL or not LTL that's the question?
|
|
5
|
429
|
April 15, 2025
|
N-Nitroso Caffeidine
|
|
3
|
118
|
April 14, 2025
|
Risk mitigation based on DP specifications
|
|
10
|
610
|
April 7, 2025
|
Evaluation of the nitrosamine impurities of ACE inhibitors using computational, in vitro, and in vivo methods demonstrate no genotoxic potential -Pub
|
|
8
|
533
|
April 2, 2025
|
N-nitrosodicyclohexylamine (NDCHA), what do you know about it?
|
|
18
|
490
|
March 21, 2025
|
AI limits and CPCA score (O=NN1CCN=C1CCl)
|
|
8
|
371
|
March 17, 2025
|