|
About the Limits of Nitrosamines category
|
|
0
|
876
|
April 14, 2021
|
|
Limits for small nitrosamines
|
|
10
|
453
|
December 6, 2024
|
|
吲哚类亚硝胺杂质怎么进行评估、计算ai值 - How to evaluate and calculate the AI value of indole nitrosamine impurities
|
|
1
|
161
|
December 1, 2024
|
|
N-Nitroso Sertraline
|
|
7
|
277
|
November 27, 2024
|
|
Tipiracil NDSRI
|
|
0
|
63
|
November 22, 2024
|
|
N-nitroso-Impurity C in Metamizol Drug product
|
|
13
|
1520
|
November 21, 2024
|
|
N-nitroso-amlodipine ; N-nitroso-felodipine ; synthesis not successfull but still listed by FDA and EMA as NDSRIs
|
|
12
|
2981
|
November 21, 2024
|
|
N-Nitroso Metoprolol
|
|
0
|
101
|
November 20, 2024
|
|
Tox Data/Testing
|
|
1
|
138
|
November 8, 2024
|
|
⁉️ Duloxetine Impurity NDSRI
|
|
7
|
616
|
November 1, 2024
|
|
Hypothetical Nitrosamine in 1-H Indazole / CPCA Approach
|
|
3
|
115
|
October 31, 2024
|
|
N-Nitroso clonidine CPCA score
|
|
2
|
154
|
October 31, 2024
|
|
N-Nitroso mirabegron
|
|
6
|
2362
|
October 30, 2024
|
|
What is CPCA Score for “N-nitroso of 3-Amino-1,2,4-triazole"
|
|
5
|
201
|
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
|
136
|
October 29, 2024
|
|
🇦🇺 TGA Australia Published Acceptable intakes for Nitrosamines
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|
3
|
1198
|
October 17, 2024
|
|
FDA Acceptable intake limit for multiple nitrosamines in one drug product -Calculation
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|
1
|
338
|
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
|
208
|
October 12, 2024
|
|
Limits of those Nitrosamines deleted from Table 1 in the guidance
|
|
2
|
383
|
October 4, 2024
|
|
Case Studies for CPCA Scoring
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|
18
|
4029
|
September 30, 2024
|
|
🖩 CPCA Calculation Tool (excel-based) -Updated
|
|
87
|
10705
|
September 27, 2024
|
|
Multiple Secondary Amine Groups in the Same Molecule
|
|
2
|
210
|
September 26, 2024
|
|
Cleaning Validation Swab Sampling for Nitrosamine Impurities
|
|
1
|
166
|
September 24, 2024
|
|
Residual limits of nitrosamine impurities in cleaning validation
|
|
0
|
123
|
September 24, 2024
|
|
Low-concentration nitrosamine impurity sample detection method
|
|
0
|
103
|
September 24, 2024
|
|
Primeros pasos para evaluar nitrosaminas en medicamentos
|
|
5
|
170
|
September 23, 2024
|
|
How to calculate limits for Di nitrosamine compounds in API, eg: 1,4-Di-ntrosopirrazine
|
|
4
|
215
|
September 11, 2024
|
|
EMA Q&A Appendix 1 is updated Sept 4, 2024
|
|
18
|
1431
|
September 6, 2024
|
|
Negative EAT could probably result in ICH Q3B?
|
|
10
|
335
|
September 5, 2024
|
|
FDA updated information on recommended AI Sept 4, 2024
|
|
1
|
450
|
September 4, 2024
|