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	3370	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…	297	9157	October 28, 2024
WHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products Guidance, Documents, Resources	4	979	December 21, 2024
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific Acceptable Intakes-Pub N-nitrosamines Chemistry NDSRI	6	331	December 19, 2024
N-nitrosoamides - a horse of a different color Risk Assessment Strategy / Tools & Technology Drug_Substance_APIs	47	5153	December 18, 2024
N-Nitroso meglumine Confirmatory Testing & Analytical Challenges	0	70	December 18, 2024
Metformin and nitrosation of guanidines New Scientific Knowledge & Development	3	90	December 18, 2024
Chemistry of N-Nitroso Ivacaftor N-nitrosamines Chemistry NDSRI	7	997	December 18, 2024
Health Canada updated nitrosamine guidance Limits of Nitrosamines	4	520	December 17, 2024
EMA nitrosamine Q&A Appendix 1 rev.7 published on Dec 13, 2024 Guidance, Documents, Resources NDSRI	6	561	December 16, 2024
AI for en Indole struktur (N-Nitroso melatonin) Limits of Nitrosamines	9	1821	December 16, 2024
Exploration for Chemical Filter Cartridges that Can Reduce Nitrogen Oxides, a Common Factor in the Formation of Nitrosamines New Scientific Knowledge & Development risk-assessment , Manufacturing	0	114	December 15, 2024
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines-Pub Limits of Nitrosamines	0	110	December 14, 2024
N-nitroso-Duloxetine recall back in the news! Events / Workshops / Webinars NDSRI	12	2026	December 13, 2024
FDA Requirement to inform about nitrosamine risk in ongoing/new clinical trials Regulatory Intelligence	2	173	December 13, 2024
Formation of Nitroso-Omeprazole N-nitrosamines Chemistry Drug_Substance_APIs	5	1693	December 12, 2024
N-nitroso-amlodipine ; N-nitroso-felodipine ; synthesis not successfull but still listed by FDA and EMA as NDSRIs Limits of Nitrosamines	14	3199	December 12, 2024
Methods to reduce false positive results Confirmatory Testing & Analytical Challenges	1	180	December 12, 2024
Limit of N-nitroso morpholine in Rocuronium Br Limits of Nitrosamines NDSRI	0	54	December 12, 2024
N-nitroso-Impurity C in Metamizol Drug product Limits of Nitrosamines	15	1591	December 12, 2024
Autonomous CPCA Web-based calculator FREE Guidance, Documents, Resources Drug_Substance_APIs , NDSRI	31	5270	December 12, 2024
Question about N-Nitroso nicardipine N-nitrosamines Chemistry	3	223	December 10, 2024
🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2 Guidance, Documents, Resources FDA	38	2580	December 9, 2024
Limits for small nitrosamines Limits of Nitrosamines	10	510	December 6, 2024
🇲🇽 Mexico Q&A Live session streaming Guidance, Documents, Resources mexico , featured	6	318	December 5, 2024
👨‍💻 FDA-CRCG NDSRI Workshop Events / Workshops / Webinars featured	0	500	December 5, 2024
Determination of N-nitroso desmethyl clarithromycin Confirmatory Testing & Analytical Challenges	2	184	December 4, 2024
📅 Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products(CRCG) Events / Workshops / Webinars NDSRI , FDA	35	2790	December 3, 2024
Free webinar: From Ambiguity to Action, The FDA's New Nitrosamine Guidance Events / Workshops / Webinars	1	553	December 2, 2024
NDMA production in the presence of formaldehyde: Competition between acid-catalyzed and formaldehyde-catalyzed reactions N-nitrosamines Chemistry	3	213	December 2, 2024

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

3370

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…