|
About the Limits of Nitrosamines category
|
|
0
|
824
|
April 14, 2021
|
|
Duloxetine Impurity NDSRI
|
|
1
|
84
|
September 12, 2024
|
|
How to calculate limits for Di nitrosamine compounds in API, eg: 1,4-Di-ntrosopirrazine
|
|
4
|
163
|
September 11, 2024
|
|
EMA Q&A Appendix 1 is updated Sept 4, 2024
|
|
18
|
652
|
September 6, 2024
|
|
Negative EAT could probably result in ICH Q3B?
|
|
10
|
280
|
September 5, 2024
|
|
FDA updated information on recommended AI Sept 4, 2024
|
|
1
|
272
|
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
|
344
|
September 3, 2024
|
|
FDA NDSRI limits not aligned with HC/EMA
|
|
0
|
363
|
August 29, 2024
|
|
N-nitroso-Impurity C in Metamizol Drug product
|
|
12
|
1353
|
August 28, 2024
|
|
Define MDD to calculate limit
|
|
45
|
15901
|
August 27, 2024
|
|
DMF in API, specification limit in formulation
|
|
5
|
660
|
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
|
102
|
August 25, 2024
|
|
NDSRI of Doxepin
|
|
6
|
513
|
August 14, 2024
|
|
Nitrosamine impurities of related substances of API's
|
|
7
|
741
|
August 12, 2024
|
|
🖩 CPCA Calculation Tool (excel-based) -Updated
|
|
84
|
9965
|
August 7, 2024
|
|
EMA Q&A Appendix 1 update posted on Feb. 26, 2024
|
|
29
|
3446
|
August 5, 2024
|
|
:australia: TGA - Latest Update to Nitrosamine Limits
|
|
5
|
1184
|
July 30, 2024
|
|
🇨🇦 Health Canada updated the guidance and Appendix 1(May 31, 2024)
|
|
18
|
2123
|
July 30, 2024
|
|
🇺🇸 FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3
|
|
16
|
3293
|
July 28, 2024
|
|
N-Nitroso mirabegron
|
|
4
|
2179
|
August 2, 2023
|
|
EMA - Appendix 1 - Update
|
|
12
|
1880
|
July 10, 2024
|
|
Nitrosamine Acceptable Intake Limits
|
|
2
|
438
|
July 10, 2024
|
|
Control limit of Nitrosamines and N-nitroso compounds
|
|
2
|
384
|
July 8, 2024
|
|
Nitroso lisinopril
|
|
3
|
346
|
July 4, 2024
|
|
Nitroso Dimethyl anthranilate
|
|
7
|
366
|
June 29, 2024
|
|
N-nitroso Solifenacin
|
|
7
|
276
|
June 28, 2024
|
|
MEGLUMINE (Methylglucamine)
|
|
18
|
2417
|
June 19, 2024
|
|
Tetrazole nitrosamines
|
|
1
|
257
|
June 13, 2024
|
|
N-Nitroso Hydrochlorothiazide in Hydrochlorothiazide drug substance
|
|
12
|
3968
|
June 11, 2024
|
|
Limit for API having two NDSRI
|
|
14
|
2197
|
June 11, 2024
|