Nitrosamines Exchange

Topic	Replies	Views	Activity
👋 Nitrosamines Exchange (and Sister Communities) is Moving to the Brand-New USP Knowledge Exchange! 🚀 Nitrosamines in the News Exciting Update: Nitrosamines Exchange (and Sister Communities) is Moving to the Brand-New USP Knowledge Exchange! :rocket: Dear Community Members, As I shared with you a few weeks ago, given the incredible success and …	0	17	October 14, 2026
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.	0	3704	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…	310	16579	July 25, 2026
US FDA on LTL adjustments for Nitrosamines Regulatory Intelligence LTL , featured	27	1335	October 14, 2026
Interferencia de matriz para cuantificación de NDBA New Scientific Knowledge & Development Excipients	1	95	October 14, 2026
Managing nitrosamine toxicological risk in late-stage development Risk Assessment Strategy / Tools & Technology NDSRI	0	14	October 14, 2026
EMA - Appendix 1 - Update Limits of Nitrosamines	103	11747	October 14, 2026
⛑️ Need your help to do user acceptance testing of the new Nitrosamine Exchange home! Nitrosamines in the News	10	219	October 14, 2026
🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments Guidance, Documents, Resources NDSRI	6	2058	October 13, 2026
Effective management of N-nitrosamines associated with leachables from packaging systems Root Causes	4	388	October 12, 2026
N-nitroso Des-ethyl Abemaciclib Confirmatory Testing & Analytical Challenges ICH-M7 , Limits , NDSRI	0	51	October 12, 2026
Synthesis of N-Nitroso Finerenone N-nitrosamines Chemistry	10	1113	October 12, 2026
Formation of N-nitroso compounds: Chemistry, kinetics, and in vivo occurrence N-nitrosamines Chemistry	0	97	October 9, 2026
Amine nitrosation mechanism (organic medium) New Scientific Knowledge & Development	1	93	October 9, 2026
In situ Formation and NNNT increase over time Confirmatory Testing & Analytical Challenges Drug_Substance_APIs , NDSRI	6	348	October 7, 2026
How to overcome blank interference at NDBA Confirmatory Testing & Analytical Challenges confirmatory	8	401	October 3, 2026
Call to review USP Risk Assessment Review Toolbox Risk Assessment Strategy / Tools & Technology	127	4343	October 2, 2026
Confirmatory testing - on how many batches? Confirmatory Testing & Analytical Challenges	6	365	October 2, 2026
Excipient nitrite levels are not static material attributes: Nitrite generation from environmental NOx and implications for drug product manufacturing New Scientific Knowledge & Development	12	810	October 2, 2026
Qualitative & Quantitative Analysis of Nitrosamines by FTIR Confirmatory Testing & Analytical Challenges	8	417	September 28, 2026
Issue Regarding Purchase of N-Nitroso N-Desmethyl Rosuvastatin Reference Standard Confirmatory Testing & Analytical Challenges NDSRI	12	535	September 26, 2026
Applicability of the ICH M7 Guidelines for Assessing Less-than-Lifetime Exposure to Nitrosamine Impurities in Drug Products-Pub Limits of Nitrosamines	10	771	September 25, 2026
Theoretical evaluation of NDSRIs Risk Assessment Strategy / Tools & Technology Drug_Substance_APIs , NDSRI	13	672	September 25, 2026
Is Sensitivity really the biggest challenge or is it sample preparation? Confirmatory Testing & Analytical Challenges NDSRI	1	206	September 24, 2026
Ng/day versus ppm - which to use with regulatory authorities? Limits of Nitrosamines	8	409	September 23, 2026
Why Accurate Nitrosamine Data Matters: Key Challenges and Considerations-Webinar Events / Workshops / Webinars	0	207	September 18, 2026
Nitrosamine Analytical Method Development Confirmatory Testing & Analytical Challenges	4	298	September 18, 2026
The Next Frontier in Nitrosamines Testing: Detection and Risk Assessment in Packaging and IV Infusion Bags Events / Workshops / Webinars	0	184	September 17, 2026
Deactivation feature on a 8-member ring with side chains? Limits of Nitrosamines	8	326	September 15, 2026
Maximum daily dose Limits of Nitrosamines	3	387	September 15, 2026

👋 Nitrosamines Exchange (and Sister Communities) is Moving to the Brand-New USP Knowledge Exchange! 🚀

Exciting Update: Nitrosamines Exchange (and Sister Communities) is Moving to the Brand-New USP Knowledge Exchange! :rocket: Dear Community Members, As I shared with you a few weeks ago, given the incredible success and …

0

17

October 14, 2026

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.

0

3704

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…