|
About the Limits of Nitrosamines category
|
|
0
|
1020
|
April 14, 2021
|
|
Nitrosamine Impurities in Excipients
|
|
2
|
115
|
December 31, 2025
|
|
Limits more than one Nitrosamine?
|
|
45
|
3083
|
December 30, 2025
|
|
N-nitrosamides, N-nitrosoureas, Nnitrosoguanidines
|
|
7
|
401
|
December 30, 2025
|
|
How to Establish MDD for Creams and Ophthalmic Solutions
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|
2
|
182
|
December 26, 2025
|
|
Establishing Best Practice for N-Nitrosamine Read-Across and Surrogate Selection
|
|
0
|
175
|
December 22, 2025
|
|
N-Nitroso vonoprazan
|
|
1
|
197
|
December 15, 2025
|
|
EMA - Appendix 1 - Update
|
|
70
|
6804
|
December 5, 2025
|
|
Nitrites in Excipients
|
|
7
|
420
|
November 28, 2025
|
|
Grenzwert für N-nitroso oxymetazoline
|
|
4
|
112
|
November 19, 2025
|
|
N-Nitroso-API calculation limit
|
|
9
|
720
|
November 13, 2025
|
|
:australia: TGA - Latest Update to Nitrosamine Limits
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|
10
|
2306
|
November 3, 2025
|
|
EMA has updated its AI limits on 01 Aug 2025
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|
17
|
2400
|
October 28, 2025
|
|
N-Nitroso Sertraline
|
|
9
|
862
|
October 23, 2025
|
|
N-Nitroso mirabegron
|
|
7
|
2678
|
October 15, 2025
|
|
Help/Information needed: Are bis-Aryl-Azoxy-compounds CoC or not?
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|
3
|
161
|
October 13, 2025
|
|
LTL Approach for New Generic Registrations
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|
5
|
426
|
October 10, 2025
|
|
Nitrosamines without published AI, and possibly negative for carcinogenicity
|
|
11
|
1275
|
October 7, 2025
|
|
Estimation of genotoxic nitroso amines impurities in empagliflozin
|
|
2
|
258
|
September 15, 2025
|
|
Alignment between Regulatory Agencies
|
|
2
|
405
|
September 12, 2025
|
|
Ask for help with limit for Nitroso-olaparib
|
|
2
|
197
|
September 4, 2025
|
|
N-nitroso-omadacycline mutagenic
|
|
3
|
124
|
September 2, 2025
|
|
Why EMA has done read-across for N-nitroso-desmethyl-doxylamine?
|
|
9
|
342
|
September 1, 2025
|
|
Why do nitrosamine impurities of omacycline and tigecycline have different AI values?
|
|
8
|
349
|
August 28, 2025
|
|
N-nitroso-Impurity C in Metamizol Drug product
|
|
27
|
2662
|
August 22, 2025
|
|
Published limit for N-Nitroso-Vonoprazan
|
|
2
|
290
|
August 15, 2025
|
|
N-nitroso-amlodipine ; N-nitroso-felodipine ; synthesis not successfull but still listed by FDA and EMA as NDSRIs
|
|
15
|
4650
|
April 16, 2025
|
|
Lifetime Cumulative Dose and Less Than Lifetime Approach
|
|
3
|
580
|
July 16, 2025
|
|
MEGLUMINE (Methylglucamine)
|
|
27
|
3337
|
July 10, 2025
|
|
Criterios de aceptación
|
|
2
|
100
|
June 26, 2025
|