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	323	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	3711	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	16729	July 25, 2026
Designing Oral Solid Drug Products to Minimize NDSRI Formation: Formulation Drivers, Mitigation Strategies and Lifecycle Control-Pub Risk Assessment Strategy / Tools & Technology NDSRI	0	14	October 22, 2026
NOx mediation - how to reduce levels N-nitrosamines Chemistry	14	307	October 22, 2026
N-Nitrosoatorvastatin and applicable potency category 4 or 5 Limits of Nitrosamines Drug_Substance_APIs	4	236	October 22, 2026
US FDA on LTL adjustments for Nitrosamines Regulatory Intelligence LTL , featured	30	1701	October 22, 2026
US FDA- Generic Drug Science and Research Priority Initiatives for Fiscal Year (FY) 2024 Nitrosamines in the News FDA	3	703	October 21, 2026
EMA/ CMDh meeting - Sept 2026 - BE requirements following formulation changes Regulatory Intelligence	0	62	October 21, 2026
N-nitroso-atorvastatin N-nitrosamines Chemistry NDSRI	4	66	October 21, 2026
EMA - Appendix 1 - Update Limits of Nitrosamines	113	12226	October 21, 2026
Why Regulators Are Questioning Paper-Only Risk Assessments Risk Assessment Strategy / Tools & Technology risk-assessment	4	191	October 20, 2026
Matrix interference for NDBA quantification -anybody? New Scientific Knowledge & Development Excipients	2	175	October 20, 2026
Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop Events / Workshops / Webinars FDA	8	602	October 19, 2026
Managing Analytical Procedure Lifecycles: Resolving Longstanding Mass Spectrometry Challenges Events / Workshops / Webinars	0	65	October 17, 2026
🇯🇵 Product recall due N-nitroso-diisopropanolamine Nitrosamines in the News	1	185	October 17, 2026
Effective management of N-nitrosamines associated with leachables from packaging systems Root Causes	7	491	October 16, 2026
LTL Application Monthly Administration Limits of Nitrosamines	1	96	October 16, 2026
🇯🇵 Recommendations by Japanese Society of Generic and Biosimilar Medicines Guidance, Documents, Resources	0	74	October 16, 2026
Managing nitrosamine toxicological risk in late-stage development Risk Assessment Strategy / Tools & Technology NDSRI	1	165	October 15, 2026
Nitrosation of bilastine N-nitrosamines Chemistry NDSRI	10	427	October 15, 2026
⛑️ Need your help to do user acceptance testing of the new Nitrosamine Exchange home! Nitrosamines in the News	10	267	October 14, 2026
🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments Guidance, Documents, Resources NDSRI	6	2096	October 13, 2026
N-nitroso Des-ethyl Abemaciclib Confirmatory Testing & Analytical Challenges ICH-M7 , Limits , NDSRI	0	82	October 12, 2026
Synthesis of N-Nitroso Finerenone N-nitrosamines Chemistry	10	1144	October 12, 2026
Formation of N-nitroso compounds: Chemistry, kinetics, and in vivo occurrence N-nitrosamines Chemistry	0	169	October 9, 2026
Amine nitrosation mechanism (organic medium) New Scientific Knowledge & Development	1	127	October 9, 2026
In situ Formation and NNNT increase over time Confirmatory Testing & Analytical Challenges Drug_Substance_APIs , NDSRI	6	366	October 7, 2026
How to overcome blank interference at NDBA Confirmatory Testing & Analytical Challenges confirmatory	8	416	October 3, 2026
Call to review USP Risk Assessment Review Toolbox Risk Assessment Strategy / Tools & Technology	127	4376	October 2, 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

323

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

3711

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…