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	3585	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…	309	13030	January 17, 2026
EMA proposes GMP update to EudraLex to address nitrosamine impurities Nitrosamines in the News Drug_Substance_APIs , featured	10	401	February 18, 2026
N-Nitroso Metamizole Impurity C Confirmatory Testing & Analytical Challenges NDSRI	0	42	February 18, 2026
Nitrites/Nitrosamines: The impacts on analytics, but not only Events / Workshops / Webinars Excipients	0	55	February 17, 2026
Calculation of Maximum Daily Dose (MDD) for 2 Strengths Limits of Nitrosamines	5	128	February 17, 2026
Advantages and limitations of the inclusion of ascorbic acid on nitrosamine mitigation in pharmaceutical drug products-Pub New Scientific Knowledge & Development Manufacturing	5	376	February 17, 2026
N-Nitroso meglumine Confirmatory Testing & Analytical Challenges	25	1574	February 16, 2026
N-Nitroso methylphenidate anybody? New Scientific Knowledge & Development	1	131	February 12, 2026
N-Nitroso Imidazole content in Clotrimazole New Scientific Knowledge & Development	9	594	February 9, 2026
Moxonidine Nitrosamines Confirmatory Testing & Analytical Challenges	2	138	February 9, 2026
👨‍💻 Quantitation of N-Nitrosodimethylamine (NDMA) and N-Nitrosophenylephrine (NNPE) in Phenylephrine Hydrochloride (API) by LC-MS/MS Analytical Methods Hub Analytical-Hub , NDSRI	0	208	February 7, 2026
👨‍💻 N-Nitroso-Propranolol Test Method & Validation Report Analytical Methods Hub NDSRI , Analytical-Hub	0	102	February 7, 2026
👨‍💻 N-Nitroso-Methylphenidate Test Method and Validation Report Analytical Methods Hub NDSRI , Analytical-Hub	0	98	February 7, 2026
N-nitroso clonixin New Scientific Knowledge & Development	3	121	February 6, 2026
Ames Concordance with the In Vivo Transgenic Rodent (TGR) Gene Mutation Assay for NDSRIs and Relative In Vivo TGR Potency with Nitrosamines with Robust Dose-Response Carcinogenicity Data-Pub Limits of Nitrosamines NDSRI	1	181	February 5, 2026
Available Tools for Prediction of Potential Degradation Products from Nitrosation Reactions Risk Assessment Strategy / Tools & Technology Drug_Substance_APIs , risk-assessment , NDSRI	4	226	February 4, 2026
N-nitroso-rivaroxaban amide Confirmatory Testing & Analytical Challenges Drug_Substance_APIs , NDSRI	7	1880	February 4, 2026
Nitrosamine control in Metformin /Vildagliptin DP Limits of Nitrosamines	6	315	February 3, 2026
The role of pH, temperature and humidity in solid/liquid DP formulations N-nitrosamines Chemistry	2	224	February 3, 2026
10th Impurities: Genotoxic, Nitrosamine, & Beyond Summit Events / Workshops / Webinars	2	288	February 2, 2026
Mutagenic Impurities in USP -future looking Guidance, Documents, Resources	7	537	February 2, 2026
Live Q&A hosted by Andy Teasdale Events / Workshops / Webinars	0	151	January 30, 2026
TGA updated Established acceptable intake for nitrosamines in medicines on 29 January 2026 Limits of Nitrosamines NDSRI	0	335	January 29, 2026
Nitrosamine Drug Substance-Related Impurities cause DNA methylation adducts in vitro and in primary hepatocytes upon Cytochrome P450-dependend metabolic activation-Pub Limits of Nitrosamines NDSRI	2	216	January 29, 2026
Sufentanil Nitroso impurity standard Confirmatory Testing & Analytical Challenges NDSRI	8	220	January 29, 2026
Nitrosation of Inosine-like compounds N-nitrosamines Chemistry	1	120	January 26, 2026
If NDSRIs are not detected at end of stability, is small-molecule nitrosamine testing still required? Confirmatory Testing & Analytical Challenges	5	222	January 23, 2026
Nitrosamine Impurities: The Analytical & Regulatory Roadmap (2024-2025) Confirmatory Testing & Analytical Challenges Excipients , risk-assessment , NDSRI	0	343	January 20, 2026
Approach for N-Nitroso Imatinib Limits: Database vs ICH S9 Limits of Nitrosamines	5	175	January 22, 2026

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

3585

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…