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	1356	August 22, 2022
About the New Scientific Knowledge & Development category	0	416	April 14, 2021
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	149	May 8, 2026
Adjusting the Preincubation Conditions to Enhance the Ames Test for Detecting the Mutagenicity of N‐Nitrosamines-Pub NDSRI	2	137	May 1, 2026
Hunt for NDSRIs: Unveiling Hidden Threats with the Novel 15N-Enriched NAP Test-Pub NDSRI	3	454	April 30, 2026
Early life exposure to N-nitrosamine drives genotoxicity, mutagenesis, and tumorigenesis in DNA repair-deficient mice -Pub	5	384	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	321	April 28, 2026
🇯🇵 Current Nitrosamine Landscape in Japan?	186	17109	April 26, 2026
Construction of a modified Arrhenius equation for predicting drug nitrosation in solid dosage form -Pub featured	4	909	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	147	April 21, 2026
Etelcalcetide Nitroamide – is this possible?	0	65	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	99	April 14, 2026
AMES Test Study Designs for Nitrosamine Mutagenicity Testing -Pub	13	1566	April 9, 2026
Society of Toxicology STO 2026 -Posters	1	103	April 7, 2026
FDA Announcement - Small Molecule Nitrosamines in Infusion Bags	17	2738	March 31, 2026
Impact of post approval quantitative changes in excipient composition on nitrosamine formation: De-risking strategy-Pub Excipients	0	128	March 23, 2026
Mutagenicity of EAT-positive NDSRIs in HepaRG spheroids-Pub NDSRI	0	69	March 20, 2026
Research on Nitrosamines in Complex Preparations NDSRI	2	190	March 17, 2026
Advantages and limitations of the inclusion of ascorbic acid on nitrosamine mitigation in pharmaceutical drug products-Pub Manufacturing	5	456	February 17, 2026
N-Nitroso methylphenidate anybody?	1	216	February 12, 2026
N-Nitroso Imidazole content in Clotrimazole	9	615	February 9, 2026
N-nitroso clonixin	3	141	February 6, 2026
NDSRI in Pyrathiazine theocolate NDSRI	3	307	December 5, 2025
Role of Carbonyl Compounds for N-Nitrosamine Formation during Nitrosation: Kinetics and Mechanisms	1	563	November 27, 2025
N-Nitrosamine Formation in Pharmaceutical Drug Products: Development and Validation of a Biased, Conservative, Predictive Model-Pub NDSRI	4	489	November 24, 2025
In Vitro Metabolism Study of NDSRIs NDSRI	3	293	November 20, 2025
Nitrosamine Contamination in Pharmaceuticals: A Retrospective Regulatory Analysis of USFDA Recalls and Risk Mitigation Strategies (2018–2025)-Pub FDA	0	240	November 18, 2025
N nitroso urapidil	0	93	November 18, 2025
Nitrosamine Control: From Risk Assessment to Analytical Testing with Emphasis on Sample Preparation and Phase-Appropriate Method Validation-Pub	0	347	November 8, 2025
Peptide Synthesis - Does anyone have experience with potential Nitrosamine impurities coming from solid phase synthesis? Drug_Substance_APIs	1	209	October 16, 2025

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 …