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	3477	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	9666	May 15, 2025
Call to review USP Risk Assessment Review Toolbox Risk Assessment Strategy / Tools & Technology	121	2965	July 12, 2025
🇯🇵 Current Nitrosamine Landscape in Japan? New Scientific Knowledge & Development	159	13915	July 11, 2025
MEGLUMINE (Methylglucamine) Limits of Nitrosamines Manufacturing , Drug_Substance_APIs , Excipients	27	2940	July 10, 2025
Unknown Impurity of Sertraline - Formamide? Confirmatory Testing & Analytical Challenges	18	508	July 10, 2025
Analytical Procedures and Validation_Specificity parameter requirment Guidance, Documents, Resources	9	368	July 9, 2025
Synthesis Attempts and Failure Report 🧐 Confirmatory Testing & Analytical Challenges	21	1120	July 7, 2025
Calling our Risk Assessment Experts Events / Workshops / Webinars risk-assessment , crowdsourcing	40	690	July 7, 2025
Addendum to ICH M7 on Risk Assessment and Control of N-Nitrosamine Impurities Guidance, Documents, Resources ICH-M7 , featured	8	1223	July 3, 2025
🇦🇷 Nitrosaminas en Fármacos. Academia Nacional de Farmacia y Bioquimica Events / Workshops / Webinars	0	112	July 1, 2025
🇨🇭 SwissMedic Nitrosamine impurities: Udpated requirements Regulatory Intelligence	1	295	July 1, 2025
Low recovery factor & Validation Issue Confirmatory Testing & Analytical Challenges validation , Drug_Substance_APIs	10	336	July 1, 2025
NDMA handling - safety measures Confirmatory Testing & Analytical Challenges	6	249	July 1, 2025
🚨 FDA deadline update Guidance, Documents, Resources FDA , deadlines	13	798	June 30, 2025
Excipient Nitrosamine Risk Assessment Tool Risk Assessment Strategy / Tools & Technology	0	181	June 30, 2025
CMO Nitrosamine Risk Assessment Risk Assessment Strategy / Tools & Technology Drug_Substance_APIs , NDSRI , risk-assessment	7	316	June 27, 2025
A greener method for analysis of nitrosamines utilising GC-NPD Confirmatory Testing & Analytical Challenges	1	59	June 27, 2025
Estimation of bioavailable concentration of endogenously formed N-nitrosamines by physiologically based kinetic modelling New Scientific Knowledge & Development	0	69	June 27, 2025
Nitrosamines in Carbamazepine? Drug Substance (APIs) Drug_Substance_APIs	5	848	June 27, 2025
Criterios de aceptación Limits of Nitrosamines	2	77	June 26, 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	10	416	June 26, 2025
Limits more than one Nitrosamine? Limits of Nitrosamines	44	2593	June 26, 2025
Quantifier and Qualifier Ion in mass spec Limits of Nitrosamines	6	145	June 26, 2025
👨‍💻 Highly sensitive and robust LC-MS/MS method for determination of up to 15 small molecule nitrosamine in pharmaceutical drug substances Analytical Methods Hub Analytical-Hub	0	166	June 25, 2025
👨‍💻 Quantification of Nitrite and Nitrate in Colloidal Silicon Dioxide by IC Analytical Methods Hub Analytical-Hub	0	106	June 25, 2025
Analytical Method Development Strategy for Controlling Two New Nitrosamine Drug Substance Related Impurities (NDSRIs) in a Pharmaceutical Drug Product for Treatment of a Rare Disease -Pub New Scientific Knowledge & Development NDSRI	0	51	June 25, 2025
N-Nitroso Phenylephrine and N-Nitroso Phenylephrone New Scientific Knowledge & Development	1	103	June 25, 2025
"Ribolaris" clinical trial has been partially suspended due to nitrosamine impurities in ribociclib batches Nitrosamines in the News	2	388	June 24, 2025
Potential Nitrosamine Formation Risk in Fluid Bed Granulation Using Povidone as Binder Solution Manufacturing Processes	9	515	June 24, 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

3477

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…