New Scientific Knowledge & Development

Topic	Replies	Views	Activity
How to avoid NDMA in Metformin? (In press) Back in October 2020, we saw an increased concern about the potential presence of NDMA in Metformin. @trust_user_a @trust_user_b @trust_user_c “As of October 2020, EMA and the national competent authorities are asking …	2	1419	August 22, 2022
About the New Scientific Knowledge & Development category	0	429	April 14, 2021
Matrix interference for NDBA quantification -anybody? Excipients	1	132	October 14, 2026
Amine nitrosation mechanism (organic medium)	1	121	October 9, 2026
Excipient nitrite levels are not static material attributes: Nitrite generation from environmental NOx and implications for drug product manufacturing	12	833	October 2, 2026
Efficacy of ultraviolet irradiation of pharmaceutical excipients in mitigating N-nitrosamine generation-Pub Excipients	4	408	September 1, 2026
Nitrosamines and their precursors in pharmaceutical packaging and potential contamination-Pub for stability chambers Packaging	0	200	August 31, 2026
FDA Announcement - Small Molecule Nitrosamines in Infusion Bags	21	3262	August 28, 2026
Mitigating Nitrosamine Risk through Twin Screw Melt Granulation in Metformin Hydrochloride	1	180	August 25, 2026
Differential Mutagenic Response of Rat Liver and Lung to Nicotine-Derived Nitrosamine Ketone (NNK)-Pub	0	119	August 5, 2026
Complex versus simple N-nitrosamines: Comprehensive genotoxicity and in silico carcinogenicity assessment toward future testing paradigms -Pub NDSRI	8	834	July 25, 2026
Which Molecule Is Involved in the Nitrosation Reaction of Pharmaceuticals: NO or NO 2 ? -Pub NDSRI	3	306	July 24, 2026
Process-dependent N-nitroso-ketamine formation during ketamine active pharmaceutical ingredient manufacturing: part I impact of process design, solvent selection, and activated carbon-Pub Drug_Substance_APIs	1	193	July 15, 2026
In Vitro Metabolism Study of NDSRIs NDSRI	4	457	July 9, 2026
Research on Nitrosamines in Complex Preparations NDSRI	4	414	July 8, 2026
Peptide Synthesis - Does anyone have experience with potential Nitrosamine impurities coming from solid phase synthesis? Drug_Substance_APIs	2	330	July 6, 2026
Risk Evaluation of N-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody–Drug Conjugates -Pub	3	497	July 6, 2026
Which carcinogenicity study should I use? Automated identification of reliable studies - PUB	0	119	June 29, 2026
Recrystallization can stop nitrosamine formation in ranitidine hydrochloride - PUB Drug_Substance_APIs	1	280	June 24, 2026
During analysis NDELA Area observed dropped in standard solution after running sample what could be the reason	1	104	June 23, 2026
The in vitro alkaline comet assay with liver models as a complementary tool for genotoxicity assessment of N-nitrosamines -Pub safety , comet	0	102	June 3, 2026
For anyone attending AAPS Summer Scientific Forum	1	167	June 1, 2026
📣 Theoretical and Experimental Assessment of Nitrosamine Risk in Industrial Solvent Recovery -Pub featured	3	706	May 29, 2026
Simulation of nitrosamine drug substance-related impurities from secondary amine-related impurities in approved human drug products -Pub	4	453	May 27, 2026
Development of an Efficient and Scalable Process for Preparing Timolol N-Nitrosamine Impurities B, C, E, H, I, J, and Their ADMET Evaluation -Pub NDSRI	2	232	May 8, 2026
Adjusting the Preincubation Conditions to Enhance the Ames Test for Detecting the Mutagenicity of N‐Nitrosamines-Pub NDSRI	2	223	May 1, 2026
Hunt for NDSRIs: Unveiling Hidden Threats with the Novel 15N-Enriched NAP Test-Pub NDSRI	3	581	April 30, 2026
Early life exposure to N-nitrosamine drives genotoxicity, mutagenesis, and tumorigenesis in DNA repair-deficient mice -Pub	5	527	April 30, 2026
Something in the air−Unveiling the role of atmospheric nitrogen oxides in nitrosamine formation from amine-containing APIs: Mechanistic insights and risk assessment-Pub Manufacturing , featured	2	567	April 28, 2026
🇯🇵 Current Nitrosamine Landscape in Japan?	186	19138	April 26, 2026

How to avoid NDMA in Metformin? (In press)

Back in October 2020, we saw an increased concern about the potential presence of NDMA in Metformin. @trust_user_a @trust_user_b @trust_user_c “As of October 2020, EMA and the national competent authorities are asking …