|
Cleaning procedure for glassware used in the analysis of nitrosamines for LC-MS/MS
|
|
2
|
420
|
May 23, 2025
|
|
Nitrosamine Mitigation: A Path to Regulatory Compliance
|
|
1
|
487
|
May 11, 2025
|
|
Nitrosourea, aromatic n-nitroso copmounds
|
|
2
|
259
|
May 2, 2025
|
|
Autonomous CPCA Web-based calculator FREE
|
|
33
|
6861
|
April 30, 2025
|
|
Annex 2 WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products
|
|
0
|
466
|
April 16, 2025
|
|
Nitrosamines Safety Operational Expert Group
|
|
0
|
158
|
April 16, 2025
|
|
Clobam Nitrosamine Impurity
|
|
0
|
148
|
April 8, 2025
|
|
Acceptance criteria for Nitrosamines Method Validation
|
|
3
|
489
|
March 14, 2025
|
|
CDER Drug Safety Priorities Fiscal Year 2023
|
|
2
|
665
|
February 27, 2025
|
|
Adjustment of the MDD with CYP inducers?
|
|
2
|
176
|
February 13, 2025
|
|
EMA nitrosamine Q&A Appendix 1 rev.7 published on Dec 13, 2024
|
|
8
|
2637
|
January 27, 2025
|
|
ICH M7 & Nitrosamines Impurities -Updates
|
|
15
|
5036
|
January 20, 2025
|
|
Control Strategy - Testing Frequency
|
|
10
|
467
|
January 20, 2025
|
|
🇲🇽 Mexico Q&A Live session streaming
|
|
7
|
766
|
January 6, 2025
|
|
Critical comparison of BMD and TD50 methods for the calculation of acceptable intakes for N-nitroso compounds -Pub
|
|
0
|
317
|
January 3, 2025
|
|
CHPA's response to the Control of Nitrosamine Impurities in Human Drugs rev.2
|
|
1
|
426
|
January 2, 2025
|
|
AI for pharmaceutical legislation, including nitrosamines
|
|
4
|
419
|
December 30, 2024
|
|
WHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products
|
|
4
|
1218
|
December 21, 2024
|
|
Methylene Blue NDSRI
|
|
6
|
627
|
November 22, 2024
|
|
New EMA Nitrosamine impurities page
|
|
0
|
471
|
November 21, 2024
|
|
Terbinafine Nitrosamines
|
|
3
|
312
|
November 14, 2024
|
|
NDSRI limit for N-nitroso Ciprofloxacin
|
|
2
|
362
|
November 1, 2024
|
|
FDA Statement on Ritonavir and NITMA
|
|
1
|
422
|
October 29, 2024
|
|
Hexamethyldisilazane (HMDS) can form Nitrosamine Impurity?
|
|
7
|
617
|
October 29, 2024
|
|
N-Nitrosamine drug substance related impurities (NDSRIs) – A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da -Pub
|
|
0
|
325
|
October 28, 2024
|
|
Nitroso Betahistine Impurity C
|
|
2
|
188
|
October 28, 2024
|
|
Use of L-cysteine as nitrite scavenging
|
|
6
|
426
|
October 25, 2024
|
|
Selection of Solvent and Positive Control Concentration for Enhanced AMES Test -Pub
|
|
0
|
137
|
October 14, 2024
|
|
Oral Liquid Formulations
|
|
4
|
246
|
October 14, 2024
|
|
🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments
|
|
5
|
1877
|
October 9, 2024
|