About the Guidance, Documents, Resources category
|
|
0
|
575
|
April 14, 2021
|
Addendum to ICH M7 on Risk Assessment and Control of N-Nitrosamine Impurities
|
|
8
|
1151
|
July 3, 2025
|
Analytical Procedures and Validation_Specificity parameter requirment
|
|
7
|
259
|
July 2, 2025
|
π¨ FDA deadline update
|
|
13
|
723
|
June 30, 2025
|
πΊπΈ FDA Control of Nitrosamine Impurities in Human Drugs revision2
|
|
61
|
4935
|
June 14, 2025
|
Cleaning procedure for glassware used in the analysis of nitrosamines for LC-MS/MS
|
|
2
|
316
|
May 23, 2025
|
EMA Q&A Rev. 22 (EMA/409815/2020 Rev.22)
|
|
4
|
604
|
May 20, 2025
|
Nitrosamine Mitigation: A Path to Regulatory Compliance
|
|
1
|
430
|
May 11, 2025
|
Nitrosourea, aromatic n-nitroso copmounds
|
|
2
|
199
|
May 2, 2025
|
Autonomous CPCA Web-based calculator FREE
|
|
33
|
6061
|
April 30, 2025
|
Annex 2 WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products
|
|
0
|
368
|
April 16, 2025
|
Nitrosamines Safety Operational Expert Group
|
|
0
|
125
|
April 16, 2025
|
Clobam Nitrosamine Impurity
|
|
0
|
111
|
April 8, 2025
|
Acceptance criteria for Nitrosamines Method Validation
|
|
3
|
368
|
March 14, 2025
|
CDER Drug Safety Priorities Fiscal Year 2023
|
|
2
|
648
|
February 27, 2025
|
Adjustment of the MDD with CYP inducers?
|
|
2
|
150
|
February 13, 2025
|
EMA nitrosamine Q&A Appendix 1 rev.7 published on Dec 13, 2024
|
|
8
|
1920
|
January 27, 2025
|
ICH M7 & Nitrosamines Impurities -Updates
|
|
15
|
4055
|
January 20, 2025
|
Control Strategy - Testing Frequency
|
|
10
|
407
|
January 20, 2025
|
π²π½ Mexico Q&A Live session streaming
|
|
7
|
681
|
January 6, 2025
|
Critical comparison of BMD and TD50 methods for the calculation of acceptable intakes for N-nitroso compounds -Pub
|
|
0
|
269
|
January 3, 2025
|
CHPA's response to the Control of Nitrosamine Impurities in Human Drugs rev.2
|
|
1
|
385
|
January 2, 2025
|
AI for pharmaceutical legislation, including nitrosamines
|
|
4
|
365
|
December 30, 2024
|
WHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products
|
|
4
|
1152
|
December 21, 2024
|
π²π½ Mexico Nitrosamine Guide published today
|
|
42
|
2864
|
November 22, 2024
|
Methylene Blue NDSRI
|
|
6
|
540
|
November 22, 2024
|
New EMA Nitrosamine impurities page
|
|
0
|
432
|
November 21, 2024
|
Terbinafine Nitrosamines
|
|
3
|
217
|
November 14, 2024
|
NDSRI limit for N-nitroso Ciprofloxacin
|
|
2
|
294
|
November 1, 2024
|
FDA Statement on Ritonavir and NITMA
|
|
1
|
337
|
October 29, 2024
|