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	3314	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…	292	8884	September 3, 2024
PMDA-USP Workshop - Nitrosamines Track Events / Workshops / Webinars	1	157	September 14, 2024
N-Nitroso Carbidopa N-nitrosamines Chemistry Drug_Substance_APIs	2	117	September 12, 2024
Duloxetine Impurity NDSRI Limits of Nitrosamines NDSRI	1	84	September 12, 2024
Can API with amide should considered a potential candidate for forming nitrosamine impurity New Scientific Knowledge & Development Drug_Substance_APIs	5	144	September 12, 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	0	93	September 11, 2024
Escaping the cohort of concern: in vitro experimental evidence supports non-mutagenicity of N-nitroso-hydrochlorothiazide New Scientific Knowledge & Development NDSRI	0	62	September 11, 2024
FDA-CDER and HESI \| Nitrosamine Ames Data Review and Method Development Workshop Events / Workshops / Webinars FDA	0	61	September 11, 2024
57th Congress of the European Societies of Toxicology (EUROTOX 2023) Events / Workshops / Webinars	1	600	September 11, 2024
How to calculate limits for Di nitrosamine compounds in API, eg: 1,4-Di-ntrosopirrazine Limits of Nitrosamines	4	163	September 11, 2024
Determining Low PPB Levels of Nitrite in Polymeric Excipients Confirmatory Testing & Analytical Challenges Excipients	0	110	September 10, 2024
Novartis pauses some trials of cancer drug Kisqali to fix manufacturing Nitrosamines in the News	13	1502	September 9, 2024
NDMA testing in metformin Guidance, Documents, Resources	5	175	September 9, 2024
🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2 Guidance, Documents, Resources FDA , featured	19	923	September 8, 2024
Metformin drugs under simulated gastric conditions can generate high nitrite-dependent levels of N-nitrosodimethylamine N-nitrosamines Chemistry	5	849	September 8, 2024
Potential Topic for an event concerning obtaining the right level of Nitrosamine Risk Assessment information from your CMOs Events / Workshops / Webinars Live-Conversations , NDSRI , Drug_Substance_APIs , Manufacturing , Excipients	23	1565	September 8, 2024
Vildaglibtin and Metformin in combinationy Guidance, Documents, Resources	2	496	September 8, 2024
EMA Q&A Appendix 1 is updated Sept 4, 2024 Limits of Nitrosamines NDSRI	18	652	September 6, 2024
Phathom Pharmaceuticals reported nitrosamine impurity in their vonoprazan-based products Nitrosamines in the News	18	2650	September 5, 2024
Negative EAT could probably result in ICH Q3B? Limits of Nitrosamines	10	280	September 5, 2024
FDA updated information on recommended AI Sept 4, 2024 Limits of Nitrosamines NDSRI	1	272	September 4, 2024
QSAR Toolbox - Free software. Any experience? Risk Assessment Strategy / Tools & Technology	18	1578	September 4, 2024
Evaluation of the nitrosamine impurities of ACE inhibitors using computational, in vitro, and in vivo methods demonstrate no genotoxic potential -Pub Limits of Nitrosamines NDSRI	7	344	September 3, 2024
Pfizer Japan Seeks Partial Change of Champix’s Approval towards Re-Supply Nitrosamines in the News NDSRI	0	124	September 2, 2024
N-Nitroso Metformin Chemistry N-nitrosamines Chemistry	2	233	September 2, 2024
N-Nitroso Tizanidine N-nitrosamines Chemistry NDSRI	1	149	August 31, 2024
USP - CPCA Nitrosamines Case Study Guidance, Documents, Resources NDSRI	7	1344	August 30, 2024
4-(nitroso(vinyl)amino)butanoic acid from Kollidon? N-nitrosamines Chemistry risk-assessment , Excipients	7	224	August 29, 2024
🇯🇵 Current Nitrosamine Landscape in Japan? New Scientific Knowledge & Development	122	11209	August 29, 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

3314

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…