|
About the Guidance, Documents, Resources category
|
|
0
|
617
|
April 14, 2021
|
|
Analysis of Nitrite in Pharmaceutical Excipients: A Multi‑Laboratory Comparative Study - PUB
|
|
1
|
187
|
April 7, 2026
|
|
Mutagenic Impurities in USP -future looking
|
|
11
|
975
|
April 2, 2026
|
|
🇲🇽 Mexico Nitrosamine Guide published today
|
|
46
|
3509
|
January 16, 2026
|
|
Nitrosamine impurity evaluation in animal health API
|
|
2
|
107
|
January 15, 2026
|
|
Evaluation of Nitrosamine impurities in animal health APIs
|
|
1
|
133
|
January 8, 2026
|
|
Liquid medicinal product with lidocaine
|
|
4
|
180
|
January 8, 2026
|
|
Nitrosamine impurities in animal health APIs
|
|
1
|
171
|
December 24, 2025
|
|
Establishing Best Practice for N- Nitrosamine Read-Across and Surrogate Selection
|
|
0
|
160
|
December 22, 2025
|
|
🇪🇬 Egypt (EDA) Public Consultation regarding the Guidelines for Nitrosamine Impurities
|
|
0
|
112
|
November 19, 2025
|
|
EMA - nitrosamines Leading Member State (LMS)
|
|
2
|
318
|
November 13, 2025
|
|
N-nitrosamine occurrence in disinfected drinking water
|
|
0
|
251
|
November 5, 2025
|
|
🖥 Nitrosamines risk from Water for Pharmaceutical Purpose according to USP
|
|
2
|
939
|
October 24, 2025
|
|
IPEC Excipient new questionnaire, October 2025
|
|
2
|
248
|
October 23, 2025
|
|
Updated: IPEC Questionnaire for Excipient Nitrosamines Risk Evaluation
|
|
2
|
611
|
October 23, 2025
|
|
Understanding nitrosamine risk in listed medicines
|
|
2
|
373
|
October 14, 2025
|
|
EMA Q&A Rev. 22 (EMA/409815/2020 Rev.22)
|
|
5
|
2337
|
October 10, 2025
|
|
🇺🇸 US FDA- Generic Drug Science and Research Priority Initiatives for Fiscal Year (FY) 2026
|
|
0
|
255
|
October 6, 2025
|
|
🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2
|
|
65
|
6064
|
October 3, 2025
|
|
Quantitative genotoxicity assessment of N-nitrosodimethylamine in mice by error-corrected next-generation sequencing and DNA methylation quantification for toxicity threshold determination
|
|
2
|
156
|
September 24, 2025
|
|
Computational Mechanistic Study on N-Nitrosation Reaction of Secondary Amines
|
|
0
|
372
|
August 25, 2025
|
|
Nitrite testing in Excipients
|
|
2
|
550
|
August 17, 2025
|
|
:canada: Health Canada Extended Deadline
|
|
5
|
711
|
August 3, 2025
|
|
Nitrosamine impurities in human medicines/ European Medicines Regulatory Network
|
|
0
|
348
|
July 29, 2025
|
|
Nitrosamine Control Strategies: From Risk Identification to Implementation
|
|
3
|
432
|
July 24, 2025
|
|
N-nitrosamine risk assessment in pharmaceuticals: Where are we from a regulatory point of view in 2025?
|
|
0
|
380
|
July 24, 2025
|
|
Highlights from the 13th meeting of the Nitrosamine Implementation Oversight Group (NIOG)
|
|
7
|
514
|
July 22, 2025
|
|
Analytical Procedures and Validation_Specificity parameter requirment
|
|
9
|
627
|
July 9, 2025
|
|
Addendum to ICH M7 on Risk Assessment and Control of N-Nitrosamine Impurities
|
|
8
|
2301
|
July 3, 2025
|
|
🚨 FDA deadline update
|
|
14
|
1320
|
August 7, 2025
|