Nitrosamines Exchange

Topic	Replies	Views	Activity
See Who Else Is A Member How-To One theme which emerged from our discussions yesterday was members here want to see who else is a member. You can visit our public member directory here.	1	3584	July 2, 2021
Introduce yourself here! About Nitrosamines Exchange Hello and welcome to the Nitrosamines Exchange Community. Whether you’re new to the topic or you’ve been a here a while, we’re really happy to have you here and helping us build knowledge and best practices to carry out…	309	13000	January 17, 2026
Ames Concordance with the In Vivo Transgenic Rodent (TGR) Gene Mutation Assay for NDSRIs and Relative In Vivo TGR Potency with Nitrosamines with Robust Dose-Response Carcinogenicity Data-Pub Limits of Nitrosamines NDSRI	1	89	February 5, 2026
N-nitroso clonixin New Scientific Knowledge & Development	1	38	February 5, 2026
Available Tools for Prediction of Potential Degradation Products from Nitrosation Reactions Risk Assessment Strategy / Tools & Technology Drug_Substance_APIs , risk-assessment , NDSRI	4	127	February 4, 2026
Moxonidine Nitrosamines Confirmatory Testing & Analytical Challenges	0	39	February 4, 2026
N-nitroso-rivaroxaban amide Confirmatory Testing & Analytical Challenges Drug_Substance_APIs , NDSRI	7	1842	February 4, 2026
Nitrosamine control in Metformin /Vildagliptin DP Limits of Nitrosamines	6	286	February 3, 2026
Https://www.vonlanthenevents.com/en/10th-impurities-genotoxic-nitrosamine Events / Workshops / Webinars	0	55	February 3, 2026
The role of pH, temperature and humidity in solid/liquid DP formulations N-nitrosamines Chemistry	2	161	February 3, 2026
10th Impurities: Genotoxic, Nitrosamine, & Beyond Summit Events / Workshops / Webinars	2	249	February 2, 2026
Mutagenic Impurities in USP -future looking Guidance, Documents, Resources	7	455	February 2, 2026
Live Q&A hosted by Andy Teasdale Events / Workshops / Webinars	0	115	January 30, 2026
TGA updated Established acceptable intake for nitrosamines in medicines on 29 January 2026 Limits of Nitrosamines NDSRI	0	274	January 29, 2026
Nitrosamine Drug Substance-Related Impurities cause DNA methylation adducts in vitro and in primary hepatocytes upon Cytochrome P450-dependend metabolic activation-Pub Limits of Nitrosamines NDSRI	2	201	January 29, 2026
Sufentanil Nitroso impurity standard Confirmatory Testing & Analytical Challenges NDSRI	8	216	January 29, 2026
Nitrosation of Inosine-like compounds N-nitrosamines Chemistry	1	116	January 26, 2026
If NDSRIs are not detected at end of stability, is small-molecule nitrosamine testing still required? Confirmatory Testing & Analytical Challenges	5	207	January 23, 2026
Nitrosamine Impurities: The Analytical & Regulatory Roadmap (2024-2025) Confirmatory Testing & Analytical Challenges Excipients , risk-assessment , NDSRI	0	330	January 20, 2026
Approach for N-Nitroso Imatinib Limits: Database vs ICH S9 Limits of Nitrosamines	5	172	January 22, 2026
EMA has updated its AI limits on 01 Aug 2025 Limits of Nitrosamines	18	2719	January 21, 2026
N-nitroso-Impurity C in Metamizol Drug product Limits of Nitrosamines	28	2851	January 21, 2026
N-Nitroso Imidazole content in Clotrimazole New Scientific Knowledge & Development	8	522	January 21, 2026
Limit of Common or Small Nitrosamine Impurities in RSM irrespective of any particular MDD Limits of Nitrosamines small-nitrosamines , risk-assessment , Drug_Substance_APIs , FDA	9	282	January 21, 2026
NDSRI growth with respect to age Root Causes NDSRI	10	290	January 21, 2026
Formation of N-nitroso dabrafenib in the dabrafenib API? N-nitrosamines Chemistry	3	115	January 21, 2026
Should we test presence of Amine/ Chloramine in Potable Water and Nitrosamine in Purified Water? About Nitrosamines Exchange Solvent_Water	2	244	January 20, 2026
🇹🇷 USP is hosting a user event (and I will be there! 👨‍🔬) Events / Workshops / Webinars	4	240	January 20, 2026
How to determine the AI limit value and LOQ when MDD is less than 880mg? Limits of Nitrosamines Drug_Substance_APIs	1	146	January 20, 2026
🇲🇽 Mexico Nitrosamine Guide published today Guidance, Documents, Resources cofepris	46	3426	January 16, 2026

See Who Else Is A Member

One theme which emerged from our discussions yesterday was members here want to see who else is a member. You can visit our public member directory here.

1

3584

July 2, 2021

Introduce yourself here!

About Nitrosamines Exchange

Hello and welcome to the Nitrosamines Exchange Community. Whether you’re new to the topic or you’ve been a here a while, we’re really happy to have you here and helping us build knowledge and best practices to carry out…