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 …	1	267	October 15, 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	3709	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	16676	July 25, 2026
EMA - Appendix 1 - Update Limits of Nitrosamines	112	12074	October 20, 2026
Why Regulators Are Questioning Paper-Only Risk Assessments Risk Assessment Strategy / Tools & Technology risk-assessment	4	133	October 20, 2026
Matrix interference for NDBA quantification -anybody? New Scientific Knowledge & Development Excipients	2	158	October 20, 2026
US FDA on LTL adjustments for Nitrosamines Regulatory Intelligence LTL , featured	29	1576	October 19, 2026
Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop Events / Workshops / Webinars FDA	8	579	October 19, 2026
NOx mediation - how to reduce levels N-nitrosamines Chemistry	13	211	October 18, 2026
Managing Analytical Procedure Lifecycles: Resolving Longstanding Mass Spectrometry Challenges Events / Workshops / Webinars	0	46	October 17, 2026
🇯🇵 Product recall due N-nitroso-diisopropanolamine Nitrosamines in the News	1	133	October 17, 2026
Effective management of N-nitrosamines associated with leachables from packaging systems Root Causes	7	477	October 16, 2026
LTL Application Monthly Administration Limits of Nitrosamines	1	71	October 16, 2026
🇯🇵 Recommendations by Japanese Society of Generic and Biosimilar Medicines Guidance, Documents, Resources	0	59	October 16, 2026
Managing nitrosamine toxicological risk in late-stage development Risk Assessment Strategy / Tools & Technology NDSRI	1	142	October 15, 2026
Nitrosation of bilastine N-nitrosamines Chemistry NDSRI	10	423	October 15, 2026
⛑️ Need your help to do user acceptance testing of the new Nitrosamine Exchange home! Nitrosamines in the News	10	257	October 14, 2026
🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments Guidance, Documents, Resources NDSRI	6	2086	October 13, 2026
N-nitroso Des-ethyl Abemaciclib Confirmatory Testing & Analytical Challenges ICH-M7 , Limits , NDSRI	0	78	October 12, 2026
Synthesis of N-Nitroso Finerenone N-nitrosamines Chemistry	10	1134	October 12, 2026
Formation of N-nitroso compounds: Chemistry, kinetics, and in vivo occurrence N-nitrosamines Chemistry	0	165	October 9, 2026
Amine nitrosation mechanism (organic medium) New Scientific Knowledge & Development	1	125	October 9, 2026
In situ Formation and NNNT increase over time Confirmatory Testing & Analytical Challenges Drug_Substance_APIs , NDSRI	6	358	October 7, 2026
How to overcome blank interference at NDBA Confirmatory Testing & Analytical Challenges confirmatory	8	411	October 3, 2026
Call to review USP Risk Assessment Review Toolbox Risk Assessment Strategy / Tools & Technology	127	4368	October 2, 2026
Confirmatory testing - on how many batches? Confirmatory Testing & Analytical Challenges	6	387	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	846	October 2, 2026
Qualitative & Quantitative Analysis of Nitrosamines by FTIR Confirmatory Testing & Analytical Challenges	8	424	September 28, 2026
Issue Regarding Purchase of N-Nitroso N-Desmethyl Rosuvastatin Reference Standard Confirmatory Testing & Analytical Challenges NDSRI	12	548	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	784	September 25, 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 …

1

267

October 15, 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

3709

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…