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	3458	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…	302	9615	May 15, 2025
🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2 Guidance, Documents, Resources FDA	61	4700	June 14, 2025
Deriving safe limits for N-nitroso-bisoprolol by error-corrected next-generation sequencing (ecNGS) and benchmark dose (BMD) analysis, integrated with QM modeling and CYP-docking analysis Limits of Nitrosamines	5	94	June 13, 2025
Calling All Nitrosamines Exchange Members: We Need Your Input! Confirmatory Testing & Analytical Challenges	7	272	June 13, 2025
How to decide if one anticancer drug is for advanced cancer? Risk Assessment Strategy / Tools & Technology risk-assessment	12	471	June 13, 2025
Nitrosamines excipient EDTA Confirmatory Testing & Analytical Challenges Excipients	3	174	June 12, 2025
Atmospheric Formation of Nitrosamines in Seoul, Korea New Scientific Knowledge & Development	0	143	June 9, 2025
Potential Nitrosamine Formation Risk in Fluid Bed Granulation Using Povidone as Binder Solution Manufacturing Processes	8	405	June 9, 2025
Using N-Nitrosodiethanolamine (NDELA) and N-Nitrosopiperidine (NPIP) Transgenic Rodent Gene Mutation Data and Quantum Mechanical Modeling to Derive Potency-Based Acceptable Intakes for NDSRIs Lacking Robust Carcinogenicity Data-Pub Limits of Nitrosamines NDSRI	0	150	June 6, 2025
Passivation with nitric acid Root Causes	4	169	June 5, 2025
Would EDTA disodium form nitrosamines? N-nitrosamines Chemistry	8	3200	June 5, 2025
Nitrite testing by UPLC-MS Confirmatory Testing & Analytical Challenges	17	2013	June 5, 2025
New Paper: Impact of antioxidant addition on drug dissolution: Implications for NDSRI mitigation biowaivers New Scientific Knowledge & Development	1	196	June 5, 2025
Analysis of N-Nitrosodimethylamine (Ndma) in Pharmaceutical Products in the Presence of High Concentration N,N-Dimethylformamide (Dmf) Confirmatory Testing & Analytical Challenges	0	100	June 5, 2025
AI limit for 1-Nitrosopiperazine Limits of Nitrosamines AI , EMA , FDA	8	247	June 4, 2025
N-Nitroso Abemaciclib N-nitrosamines Chemistry NDSRI	8	195	June 4, 2025
🇯🇵 Current Nitrosamine Landscape in Japan? New Scientific Knowledge & Development	151	13558	June 3, 2025
👨‍💻 Quantitative Analysis of N-Nitrosodimethylamine in Metformin HCl by Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry Analytical Methods Hub Drug_Substance_APIs , Analytical-Hub	4	230	June 3, 2025
Synthesis Attempts and Failure Report 🧐 Confirmatory Testing & Analytical Challenges	20	965	June 3, 2025
¹⁵N-Enriched NAP Test N-nitrosamines Chemistry NDSRI	0	161	May 31, 2025
Addendum to ICH M7 on Risk Assessment and Control of N-Nitrosamine Impurities Guidance, Documents, Resources ICH-M7 , featured	7	903	May 30, 2025
EMA - Appendix 1 - Update Limits of Nitrosamines	57	5020	May 30, 2025
Nitrosamine from Cleaning Agents? Root Causes	9	1364	May 29, 2025
Limits for NDMA in Dapagliflozin+Metformin Limits of Nitrosamines	19	368	May 28, 2025
📖 Drug Substance and Drug Product Workflows for Quality Risk Management for the Presence of Nitrosamines in Medicines-Pub Risk Assessment Strategy / Tools & Technology risk-assessment , featured	2	358	May 27, 2025
Comparative DNA damage induced by 8 nitrosamines in primary human and macaque hepatocytes -Pub New Scientific Knowledge & Development mutagenicity , carconogenicity , safety	1	112	May 27, 2025
What if the answer you’re looking for is already here, with someone in this community? Confirmatory Testing & Analytical Challenges featured	7	729	May 27, 2025
Separation of Nitrosamines and Ranitidine Confirmatory Testing & Analytical Challenges Drug_Substance_APIs	3	192	May 27, 2025
Determination of N-nitroso desmethyl Tetracycline Confirmatory Testing & Analytical Challenges	10	691	May 27, 2025

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

3458

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…