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	1341	August 22, 2022
About the New Scientific Knowledge & Development category	0	413	April 14, 2021
Stability Assessment of FDA Approved Varenicline Tartrate Products for Critical Quality Attributes – N-Nitroso Varenicline, Solid Form, and Dissolution-Pub NDSRI	1	33	April 14, 2026
AMES Test Study Designs for Nitrosamine Mutagenicity Testing -Pub	13	1533	April 9, 2026
Society of Toxicology STO 2026 -Posters	1	86	April 7, 2026
FDA Announcement - Small Molecule Nitrosamines in Infusion Bags	17	2691	March 31, 2026
Impact of post approval quantitative changes in excipient composition on nitrosamine formation: De-risking strategy-Pub Excipients	0	121	March 23, 2026
Mutagenicity of EAT-positive NDSRIs in HepaRG spheroids-Pub NDSRI	0	67	March 20, 2026
Research on Nitrosamines in Complex Preparations NDSRI	2	181	March 17, 2026
🇯🇵 Current Nitrosamine Landscape in Japan?	183	16953	March 1, 2026
Advantages and limitations of the inclusion of ascorbic acid on nitrosamine mitigation in pharmaceutical drug products-Pub Manufacturing	5	449	February 17, 2026
N-Nitroso methylphenidate anybody?	1	188	February 12, 2026
N-Nitroso Imidazole content in Clotrimazole	9	611	February 9, 2026
N-nitroso clonixin	3	138	February 6, 2026
Hunt for NDSRIs: Unveiling Hidden Threats with the Novel 15N-Enriched NAP Test-Pub NDSRI	2	382	January 7, 2026
NDSRI in Pyrathiazine theocolate NDSRI	3	298	December 5, 2025
Role of Carbonyl Compounds for N-Nitrosamine Formation during Nitrosation: Kinetics and Mechanisms	1	554	November 27, 2025
N-Nitrosamine Formation in Pharmaceutical Drug Products: Development and Validation of a Biased, Conservative, Predictive Model-Pub NDSRI	4	470	November 24, 2025
In Vitro Metabolism Study of NDSRIs NDSRI	3	281	November 20, 2025
Nitrosamine Contamination in Pharmaceuticals: A Retrospective Regulatory Analysis of USFDA Recalls and Risk Mitigation Strategies (2018–2025)-Pub FDA	0	229	November 18, 2025
N nitroso urapidil	0	89	November 18, 2025
Nitrosamine Control: From Risk Assessment to Analytical Testing with Emphasis on Sample Preparation and Phase-Appropriate Method Validation-Pub	0	341	November 8, 2025
Construction of a modified Arrhenius equation for predicting drug nitrosation in solid dosage form -Pub featured	2	791	October 30, 2025
Peptide Synthesis - Does anyone have experience with potential Nitrosamine impurities coming from solid phase synthesis? Drug_Substance_APIs	1	203	October 16, 2025
Sample Prep for Complex Matrices - creams etc?	1	184	October 10, 2025
Monitoring the Concentration of Nitrogen Oxides in the Fluidized Bed Drying/Granulation Process and Evaluation of Reduction Methods Manufacturing , risk-assessment	2	499	September 28, 2025
A Simple and Scalable Synthesis of N-Nitroso Salbutamol Impurities A, D, and F -Pub	1	158	September 27, 2025
Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation NDSRI , featured	18	5186	September 20, 2025
Nitrosamines risk in cleaning validation approach Live-Conversations , risk-assessment , Manufacturing , NDSRI	11	380	September 4, 2025
N-nitrosamines: in silico modelling of DNA reactivity and identification of metabolic precursors	0	168	August 12, 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 …