|
About the Guidance, Documents, Resources category
|
|
0
|
632
|
April 14, 2021
|
|
Regulatory Flexibilities and Clarifications: Chemistry, Manufacturing and Control (CMC) Information for Original First in Human (FIH) Phase 1 INDs
|
|
1
|
222
|
June 25, 2026
|
|
Requirements for NAs assessment in Russia
|
|
6
|
302
|
June 23, 2026
|
|
Upcoming EMA Q&A for other nitrosocompounds
|
|
3
|
418
|
June 5, 2026
|
|
An updated version of Health Canada's Guidance on nitrosamine impurities in medications(Update May 29, 2026)
|
|
0
|
253
|
June 2, 2026
|
|
Analysis of Nitrite in Pharmaceutical Excipients: A Multi‑Laboratory Comparative Study - PUB
|
|
3
|
436
|
June 1, 2026
|
|
🇰🇷 MFDS Guideline: Compilation of Analysis Methods on the Determination of Impurities in Pharmaceuticals, May-2026
|
|
2
|
277
|
May 19, 2026
|
|
Mutagenic Impurities in USP -future looking
|
|
16
|
1413
|
May 14, 2026
|
|
N-Nitroso Mefanaminc Acid
|
|
1
|
146
|
May 12, 2026
|
|
N-Nitroso dially amine estimation by LCMS
|
|
2
|
91
|
April 29, 2026
|
|
🇲🇽 Mexico Nitrosamine Guide published today
|
|
46
|
3783
|
January 16, 2026
|
|
Nitrosamine impurity evaluation in animal health API
|
|
2
|
117
|
January 15, 2026
|
|
Evaluation of Nitrosamine impurities in animal health APIs
|
|
1
|
149
|
January 8, 2026
|
|
Liquid medicinal product with lidocaine
|
|
4
|
199
|
January 8, 2026
|
|
Nitrosamine impurities in animal health APIs
|
|
1
|
196
|
December 24, 2025
|
|
Establishing Best Practice for N- Nitrosamine Read-Across and Surrogate Selection
|
|
0
|
176
|
December 22, 2025
|
|
🇪🇬 Egypt (EDA) Public Consultation regarding the Guidelines for Nitrosamine Impurities
|
|
0
|
118
|
November 19, 2025
|
|
EMA - nitrosamines Leading Member State (LMS)
|
|
2
|
340
|
November 13, 2025
|
|
N-nitrosamine occurrence in disinfected drinking water
|
|
0
|
255
|
November 5, 2025
|
|
🖥 Nitrosamines risk from Water for Pharmaceutical Purpose according to USP
|
|
2
|
997
|
October 24, 2025
|
|
IPEC Excipient new questionnaire, October 2025
|
|
2
|
273
|
October 23, 2025
|
|
Updated: IPEC Questionnaire for Excipient Nitrosamines Risk Evaluation
|
|
2
|
703
|
October 23, 2025
|
|
Understanding nitrosamine risk in listed medicines
|
|
2
|
433
|
October 14, 2025
|
|
EMA Q&A Rev. 22 (EMA/409815/2020 Rev.22)
|
|
5
|
2778
|
October 10, 2025
|
|
🇺🇸 US FDA- Generic Drug Science and Research Priority Initiatives for Fiscal Year (FY) 2026
|
|
0
|
274
|
October 6, 2025
|
|
🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2
|
|
65
|
6378
|
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
|
212
|
September 24, 2025
|
|
Computational Mechanistic Study on N-Nitrosation Reaction of Secondary Amines
|
|
0
|
377
|
August 25, 2025
|
|
Nitrite testing in Excipients
|
|
2
|
628
|
August 17, 2025
|
|
:canada: Health Canada Extended Deadline
|
|
5
|
760
|
August 3, 2025
|