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	3582	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	12991	January 17, 2026
Available Tools for Prediction of Potential Degradation Products from Nitrosation Reactions Risk Assessment Strategy / Tools & Technology Drug_Substance_APIs , risk-assessment , NDSRI	0	13	February 3, 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	0	13	February 3, 2026
Nitrosamine control in Metformin /Vildagliptin DP Limits of Nitrosamines	6	252	February 3, 2026
Https://www.vonlanthenevents.com/en/10th-impurities-genotoxic-nitrosamine Events / Workshops / Webinars	0	21	February 3, 2026
The role of pH, temperature and humidity in solid/liquid DP formulations N-nitrosamines Chemistry	2	97	February 3, 2026
10th Impurities: Genotoxic, Nitrosamine, & Beyond Summit Events / Workshops / Webinars	2	231	February 2, 2026
Mutagenic Impurities in USP -future looking Guidance, Documents, Resources	7	370	February 2, 2026
Live Q&A hosted by Andy Teasdale Events / Workshops / Webinars	0	77	January 30, 2026
TGA updated Established acceptable intake for nitrosamines in medicines on 29 January 2026 Limits of Nitrosamines NDSRI	0	169	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	193	January 29, 2026
Sufentanil Nitroso impurity standard Confirmatory Testing & Analytical Challenges NDSRI	8	213	January 29, 2026
Nitrosation of Inosine-like compounds N-nitrosamines Chemistry	1	113	January 26, 2026
If NDSRIs are not detected at end of stability, is small-molecule nitrosamine testing still required? Confirmatory Testing & Analytical Challenges	5	203	January 23, 2026
Nitrosamine Impurities: The Analytical & Regulatory Roadmap (2024-2025) Confirmatory Testing & Analytical Challenges Excipients , risk-assessment , NDSRI	0	320	January 20, 2026
Approach for N-Nitroso Imatinib Limits: Database vs ICH S9 Limits of Nitrosamines	5	170	January 22, 2026
EMA has updated its AI limits on 01 Aug 2025 Limits of Nitrosamines	18	2696	January 21, 2026
N-nitroso-Impurity C in Metamizol Drug product Limits of Nitrosamines	28	2844	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	277	January 21, 2026
NDSRI growth with respect to age Root Causes NDSRI	10	281	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	242	January 20, 2026
🇹🇷 USP is hosting a user event (and I will be there! 👨‍🔬) Events / Workshops / Webinars	4	234	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	140	January 20, 2026
🇲🇽 Mexico Nitrosamine Guide published today Guidance, Documents, Resources cofepris	46	3421	January 16, 2026
Impact of nitrocellulose-free foil on dry powder product performance and stability Packaging Packaging	4	254	January 15, 2026
Nitrosamine impurity evaluation in animal health API Guidance, Documents, Resources risk-assessment	2	96	January 15, 2026
🇪🇬 EDA Workshop: Nitrosamine Impurities, Risk Assessment, Control Strategies, and Regulatory Compliance Events / Workshops / Webinars	3	321	January 14, 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

3582

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…