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	1414	August 22, 2022
About the New Scientific Knowledge & Development category	0	429	April 14, 2021
Excipient nitrite levels are not static material attributes: Nitrite generation from environmental NOx and implications for drug product manufacturing	12	786	October 2, 2026
Efficacy of ultraviolet irradiation of pharmaceutical excipients in mitigating N-nitrosamine generation-Pub Excipients	4	400	September 1, 2026
Nitrosamines and their precursors in pharmaceutical packaging and potential contamination-Pub for stability chambers Packaging	0	191	August 31, 2026
FDA Announcement - Small Molecule Nitrosamines in Infusion Bags	21	3233	August 28, 2026
Mitigating Nitrosamine Risk through Twin Screw Melt Granulation in Metformin Hydrochloride	1	175	August 25, 2026
Differential Mutagenic Response of Rat Liver and Lung to Nicotine-Derived Nitrosamine Ketone (NNK)-Pub	0	116	August 5, 2026
Complex versus simple N-nitrosamines: Comprehensive genotoxicity and in silico carcinogenicity assessment toward future testing paradigms -Pub NDSRI	8	803	July 25, 2026
Which Molecule Is Involved in the Nitrosation Reaction of Pharmaceuticals: NO or NO 2 ? -Pub NDSRI	3	304	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	187	July 15, 2026
In Vitro Metabolism Study of NDSRIs NDSRI	4	452	July 9, 2026
Research on Nitrosamines in Complex Preparations NDSRI	4	405	July 8, 2026
Peptide Synthesis - Does anyone have experience with potential Nitrosamine impurities coming from solid phase synthesis? Drug_Substance_APIs	2	323	July 6, 2026
Risk Evaluation of N-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody–Drug Conjugates -Pub	3	488	July 6, 2026
Which carcinogenicity study should I use? Automated identification of reliable studies - PUB	0	117	June 29, 2026
Recrystallization can stop nitrosamine formation in ranitidine hydrochloride - PUB Drug_Substance_APIs	1	274	June 24, 2026
During analysis NDELA Area observed dropped in standard solution after running sample what could be the reason	1	101	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	101	June 3, 2026
For anyone attending AAPS Summer Scientific Forum	1	161	June 1, 2026
📣 Theoretical and Experimental Assessment of Nitrosamine Risk in Industrial Solvent Recovery -Pub featured	3	689	May 29, 2026
Simulation of nitrosamine drug substance-related impurities from secondary amine-related impurities in approved human drug products -Pub	4	447	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	227	May 8, 2026
Adjusting the Preincubation Conditions to Enhance the Ames Test for Detecting the Mutagenicity of N‐Nitrosamines-Pub NDSRI	2	218	May 1, 2026
Hunt for NDSRIs: Unveiling Hidden Threats with the Novel 15N-Enriched NAP Test-Pub NDSRI	3	572	April 30, 2026
Early life exposure to N-nitrosamine drives genotoxicity, mutagenesis, and tumorigenesis in DNA repair-deficient mice -Pub	5	520	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	550	April 28, 2026
🇯🇵 Current Nitrosamine Landscape in Japan?	186	19044	April 26, 2026
Construction of a modified Arrhenius equation for predicting drug nitrosation in solid dosage form -Pub featured	4	1241	April 21, 2026
Mutagenic and carcinogenic potency determinations for NDMA support the cumulative dose assumption underpinning the less-than-lifetime Threshold of Toxicological Concern -Pub LTL	0	187	April 21, 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 …