|
Omission of specification <10% AI
|
|
2
|
1011
|
September 12, 2023
|
|
Read-across/SAR posts Collection
|
|
10
|
2974
|
September 7, 2023
|
|
Kinetic model to estimate the amount of nitrosamines
|
|
5
|
891
|
September 6, 2023
|
|
Higher limits allowed by FDA for Nitroso-sitagliptin
|
|
20
|
4896
|
August 28, 2023
|
|
Nitroso-methylphenidate
|
|
4
|
719
|
August 25, 2023
|
|
CPCA - Methyl group bonded to beta carbon (cyclic/acyclic) (activating factor)
|
|
2
|
1327
|
August 23, 2023
|
|
N-Nitroso N-Desmethyl Nefopam
|
|
4
|
970
|
August 18, 2023
|
|
Total impurities limit if more than one nitrosamine impurities are observed in product
|
|
4
|
682
|
August 14, 2023
|
|
N-nitroso-hydrochlorothiazide limit
|
|
2
|
616
|
August 14, 2023
|
|
Testing of APIs for NDSRI
|
|
4
|
1082
|
August 10, 2023
|
|
Common nitrosamine impurity limit calculation when it is contributing from both API as well as excipients
|
|
9
|
1301
|
August 8, 2023
|
|
NDMA in Drug Product
|
|
2
|
542
|
August 3, 2023
|
|
Use of the less-than lifetime (LTL) concept or the use of interim limits
|
|
3
|
989
|
August 1, 2023
|
|
LTL in simple terms?
|
|
7
|
707
|
July 1, 2022
|
|
N-nitroso desloratadine?
|
|
13
|
1800
|
July 22, 2023
|
|
How important clinically are nitrosamines?
|
|
5
|
473
|
July 19, 2023
|
|
Proposed approach to Temporary Acceptable intake Limits for NDSRIs
|
|
10
|
1376
|
July 6, 2023
|
|
Limits of nitrosamine impurity below 10 ppm in drug products
|
|
0
|
704
|
June 19, 2023
|
|
Limits for N-nitroso vortioxetine
|
|
3
|
1326
|
June 15, 2023
|
|
The 18 ng/day default for NDSRIs should be re-visited?
|
|
8
|
928
|
June 14, 2023
|
|
CMDh mandated the SWP/NcWP for AI derivations of N-nitrosamines
|
|
6
|
970
|
June 10, 2023
|
|
FDA/HESI Collaborative Roadmap: Advancing Hazard and Risk Assessment of Nitrosamine Impurities in Pharmaceuticals
|
|
2
|
925
|
June 5, 2023
|
|
Establishing acceptable intakes (AI) for complex nitrosamines (NDSRIs)
|
|
16
|
1783
|
June 4, 2023
|
|
Fda行业指南中总亚硝胺杂质含量要求
|
|
1
|
687
|
June 2, 2023
|
|
Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses
|
|
2
|
808
|
June 1, 2023
|
|
N-nitroso Des-methyl Dapoxetine
|
|
12
|
1247
|
May 31, 2023
|
|
✌️Need✌️ your input on NDSRIs challenges?
|
|
33
|
3223
|
May 26, 2023
|
|
FDA Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
|
|
1
|
1545
|
May 24, 2023
|
|
The acceptance Intake of Nitroso-Propranolol
|
|
16
|
3595
|
May 24, 2023
|
|
Mutagenic impurities in pharmaceuticals: A critical assessment of the cohort of concern with a focus on N-nitrosamines
|
|
2
|
1007
|
May 23, 2023
|