|
Testig method for nitroso Ciprofloxacin
|
|
12
|
985
|
February 16, 2024
|
|
🌎 Our community in the world!
|
|
0
|
320
|
February 6, 2024
|
|
Nitrosamine testing results
|
|
10
|
673
|
April 18, 2024
|
|
Whether N-Nitroso Memantine is possible?
|
|
16
|
640
|
April 10, 2024
|
|
Nitrosamines without published AI, and possibly negative for carcinogenicity
|
|
9
|
880
|
September 18, 2023
|
|
Are nitrosamines the connecting link or one of the connecting links between the concepts of phototoxicity and photocarcinogenicity due to the intake of a contaminated medication according to the 2019/ 2023 FDA list?
|
|
40
|
675
|
April 14, 2024
|
|
N-nitroso cyclamate
|
|
9
|
385
|
March 15, 2024
|
|
N-nitroso-Impurity C in Metamizol Drug product
|
|
11
|
1084
|
January 22, 2024
|
|
Limit for API having two NDSRI
|
|
9
|
1095
|
November 21, 2023
|
|
Nitrosamines in EDQM 2023 Webinar Series
|
|
7
|
1029
|
August 10, 2023
|
|
Secondary amine Risk Assessment
|
|
9
|
971
|
June 1, 2023
|
|
EDQM - European Pharmacopeia - Feedback Nitrosamines
|
|
3
|
841
|
January 12, 2024
|
|
Quantitation of Reactive Nitrosating Agents in Pharmaceutical Excipients for N‑Nitrosamine Risk Assessments
|
|
4
|
1009
|
September 7, 2023
|
|
The Nitrosamine “Saga”
|
|
3
|
1474
|
July 29, 2023
|
|
Guideline ANVISA - Brazil: version 3, updates
|
|
8
|
2690
|
June 19, 2023
|
|
Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses
|
|
2
|
712
|
June 1, 2023
|
|
:australia: TGA - Latest Update to Nitrosamine Limits
|
|
1
|
444
|
May 6, 2024
|
|
🎄 Happy Holiday and a Nitrosamines-free 2024!
|
|
8
|
688
|
January 7, 2024
|
|
🇨🇦 Health Canada Nitrosamine Guide update
|
|
5
|
1619
|
October 27, 2023
|
|
HESI Open call to Q(SAR) and QM working group
|
|
3
|
511
|
February 20, 2024
|
|
Fifth Nitrosamine Implementation Oversight Group (NIOG) – meeting with pharmaceutical industry
|
|
1
|
595
|
September 6, 2023
|
|
Mutagenic impurities in pharmaceuticals: A critical assessment of the cohort of concern with a focus on N-nitrosamines
|
|
2
|
879
|
May 23, 2023
|
|
WHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products
|
|
3
|
727
|
April 24, 2024
|
|
Potential Event with USP & Health Authorities
|
|
8
|
642
|
February 2, 2024
|
|
🇬🇧 MHRA publishes guidelines for Nitrosamine Impurities
|
|
4
|
1141
|
August 28, 2023
|
|
TGA Australia Published Acceptable intakes for Nitrosamines
|
|
1
|
918
|
October 18, 2023
|
|
N-nitroso ticagrelor
|
|
3
|
1198
|
November 23, 2023
|
|
MCC with nitrite levels of 0.1 ppm or less
|
|
4
|
746
|
March 4, 2024
|
|
Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Rodent Carcinogenic Potency -Pub
|
|
0
|
477
|
February 6, 2024
|
|
🇺🇸 FDA CDER Generic Drug Forum (GDF) 2024
|
|
5
|
845
|
April 14, 2024
|
|
New data released into Lhasa Carcinogenicity Database
|
|
1
|
617
|
November 17, 2023
|
|
Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
|
|
3
|
780
|
July 26, 2023
|
|
Upcoming and recorded Lhasa webinars
|
|
3
|
782
|
December 21, 2023
|
|
Confidence score calculation for the carcinogenic potency categorization approach (CPCA) predictions for N-nitrosamines
|
|
5
|
1016
|
January 11, 2024
|
|
TGA (Australia) :australia: Updates Published Acceptable Intakes
|
|
3
|
549
|
February 7, 2024
|
|
🇪🇺 OMCL Network published NDSRIs Analytical Methods
|
|
1
|
709
|
March 11, 2024
|
|
🇪🇺 EMA/409815/2020 Rev.20
|
|
7
|
2166
|
January 31, 2024
|
|
FDA Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
|
|
1
|
1284
|
May 24, 2023
|
|
Nitrite Detection at Picogram Level, is it possible?
|
|
4
|
827
|
September 14, 2023
|
|
🇺🇸 FDA Recommended AI Limits for Certain Hypothetical NDSRIs
|
|
0
|
996
|
August 8, 2023
|
|
EMA - Update Appendix 3: Enhanced Ames Test conditions for N-nitrosamines
|
|
8
|
866
|
April 2, 2024
|
|
Review of nitrosamine drug substance related impurities (ndsri) in pharmaceutical drugs
|
|
1
|
584
|
October 31, 2023
|
|
Understanding the Impact Nitrosamine Impurities Can Have in the Work of Pharmacy Professionals
|
|
0
|
430
|
May 11, 2023
|
|
Updated: IPEC Position Paper on Role of Excipients in Determining N-Nitrosamine Risks for Drug Products
|
|
3
|
649
|
March 7, 2024
|
|
CPCA - Methyl group bonded to beta carbon (cyclic/acyclic) (activating factor)
|
|
2
|
941
|
August 23, 2023
|
|
USP-NF General Notices Revision open for Comments
|
|
0
|
630
|
March 7, 2024
|
|
European Pharmacopoeia Commission revises position on nitrosamine impurities
|
|
2
|
557
|
July 28, 2023
|
|
European Pharmacopeia - Open for comments 'N-Nitrosamines in active substance and medicinal products'
|
|
0
|
583
|
December 19, 2023
|
|
Identifying the Risk of Formation of Nitrosamines and Other Potentially Mutagenic Impurities during API Manufacture Using In Silico Risk Assessment -Pub
|
|
0
|
1029
|
June 6, 2023
|
|
FDA - Pharmaceutical Quality Symposium
|
|
1
|
716
|
November 1, 2023
|