|
About the Limits of Nitrosamines category
|
|
0
|
864
|
April 14, 2021
|
|
Limits for small nitrosamines
|
|
5
|
91
|
November 16, 2024
|
|
Tox Data/Testing
|
|
1
|
126
|
November 8, 2024
|
|
⁉️ Duloxetine Impurity NDSRI
|
|
7
|
584
|
November 1, 2024
|
|
Hypothetical Nitrosamine in 1-H Indazole / CPCA Approach
|
|
3
|
108
|
October 31, 2024
|
|
N-Nitroso clonidine CPCA score
|
|
2
|
130
|
October 31, 2024
|
|
N-Nitroso mirabegron
|
|
6
|
2338
|
October 30, 2024
|
|
What is CPCA Score for “N-nitroso of 3-Amino-1,2,4-triazole"
|
|
5
|
178
|
October 30, 2024
|
|
Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA) -Pub
|
|
0
|
114
|
October 29, 2024
|
|
🇦🇺 TGA Australia Published Acceptable intakes for Nitrosamines
|
|
3
|
1186
|
October 17, 2024
|
|
FDA Acceptable intake limit for multiple nitrosamines in one drug product -Calculation
|
|
1
|
325
|
October 16, 2024
|
|
西格列汀相关亚硝胺杂质(nttp)的ai值 - AI value of sitagliptin related impurity
|
|
2
|
200
|
October 12, 2024
|
|
Limits of those Nitrosamines deleted from Table 1 in the guidance
|
|
2
|
376
|
October 4, 2024
|
|
Case Studies for CPCA Scoring
|
|
18
|
4005
|
September 30, 2024
|
|
🖩 CPCA Calculation Tool (excel-based) -Updated
|
|
87
|
10591
|
September 27, 2024
|
|
Multiple Secondary Amine Groups in the Same Molecule
|
|
2
|
207
|
September 26, 2024
|
|
Cleaning Validation Swab Sampling for Nitrosamine Impurities
|
|
1
|
160
|
September 24, 2024
|
|
Residual limits of nitrosamine impurities in cleaning validation
|
|
0
|
119
|
September 24, 2024
|
|
Low-concentration nitrosamine impurity sample detection method
|
|
0
|
103
|
September 24, 2024
|
|
Primeros pasos para evaluar nitrosaminas en medicamentos
|
|
5
|
157
|
September 23, 2024
|
|
How to calculate limits for Di nitrosamine compounds in API, eg: 1,4-Di-ntrosopirrazine
|
|
4
|
211
|
September 11, 2024
|
|
EMA Q&A Appendix 1 is updated Sept 4, 2024
|
|
18
|
1264
|
September 6, 2024
|
|
Negative EAT could probably result in ICH Q3B?
|
|
10
|
332
|
September 5, 2024
|
|
FDA updated information on recommended AI Sept 4, 2024
|
|
1
|
403
|
September 4, 2024
|
|
Evaluation of the nitrosamine impurities of ACE inhibitors using computational, in vitro, and in vivo methods demonstrate no genotoxic potential -Pub
|
|
7
|
384
|
September 3, 2024
|
|
FDA NDSRI limits not aligned with HC/EMA
|
|
0
|
388
|
August 29, 2024
|
|
N-nitroso-Impurity C in Metamizol Drug product
|
|
12
|
1430
|
August 28, 2024
|
|
Define MDD to calculate limit
|
|
45
|
17056
|
August 27, 2024
|
|
DMF in API, specification limit in formulation
|
|
5
|
695
|
August 26, 2024
|
|
Evaluation of the nitrosamine impurities of ACE inhibitors using computational, in vitro, and in vivo methods demonstrate no genotoxic potential-Pub
|
|
0
|
104
|
August 25, 2024
|