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 …	3	1383	August 22, 2022
About the New Scientific Knowledge & Development category	0	421	April 14, 2021
In Vitro Metabolism Study of NDSRIs NDSRI	4	373	July 9, 2026
Research on Nitrosamines in Complex Preparations NDSRI	4	336	July 8, 2026
Peptide Synthesis - Does anyone have experience with potential Nitrosamine impurities coming from solid phase synthesis? Drug_Substance_APIs	2	274	July 6, 2026
Risk Evaluation of N-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody–Drug Conjugates -Pub	3	421	July 6, 2026
Which carcinogenicity study should I use? Automated identification of reliable studies - PUB	0	103	June 29, 2026
Recrystallization can stop nitrosamine formation in ranitidine hydrochloride - PUB Drug_Substance_APIs	1	227	June 24, 2026
During analysis NDELA Area observed dropped in standard solution after running sample what could be the reason	1	87	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	82	June 3, 2026
Complex versus simple N-nitrosamines: Comprehensive genotoxicity and in silico carcinogenicity assessment toward future testing paradigms -Pub NDSRI	7	574	June 3, 2026
For anyone attending AAPS Summer Scientific Forum	1	128	June 1, 2026
📣 Theoretical and Experimental Assessment of Nitrosamine Risk in Industrial Solvent Recovery -Pub featured	3	468	May 29, 2026
Simulation of nitrosamine drug substance-related impurities from secondary amine-related impurities in approved human drug products -Pub	4	370	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	182	May 8, 2026
Adjusting the Preincubation Conditions to Enhance the Ames Test for Detecting the Mutagenicity of N‐Nitrosamines-Pub NDSRI	2	171	May 1, 2026
Hunt for NDSRIs: Unveiling Hidden Threats with the Novel 15N-Enriched NAP Test-Pub NDSRI	3	503	April 30, 2026
Early life exposure to N-nitrosamine drives genotoxicity, mutagenesis, and tumorigenesis in DNA repair-deficient mice -Pub	5	463	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	441	April 28, 2026
🇯🇵 Current Nitrosamine Landscape in Japan?	186	17765	April 26, 2026
Construction of a modified Arrhenius equation for predicting drug nitrosation in solid dosage form -Pub featured	4	1056	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	165	April 21, 2026
Etelcalcetide Nitroamide – is this possible?	0	81	April 18, 2026
Stability Assessment of FDA Approved Varenicline Tartrate Products for Critical Quality Attributes – N-Nitroso Varenicline, Solid Form, and Dissolution-Pub NDSRI	2	129	April 14, 2026
AMES Test Study Designs for Nitrosamine Mutagenicity Testing -Pub	13	1653	April 9, 2026
Society of Toxicology STO 2026 -Posters	1	123	April 7, 2026
FDA Announcement - Small Molecule Nitrosamines in Infusion Bags	17	2918	March 31, 2026
Impact of post approval quantitative changes in excipient composition on nitrosamine formation: De-risking strategy-Pub Excipients	0	140	March 23, 2026
Mutagenicity of EAT-positive NDSRIs in HepaRG spheroids-Pub NDSRI	0	83	March 20, 2026
Advantages and limitations of the inclusion of ascorbic acid on nitrosamine mitigation in pharmaceutical drug products-Pub Manufacturing	5	500	February 17, 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 …