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	1311	August 22, 2022
About the New Scientific Knowledge & Development category	0	407	April 14, 2021
NDSRI in Pyrathiazine theocolate NDSRI	3	271	December 5, 2025
Role of Carbonyl Compounds for N-Nitrosamine Formation during Nitrosation: Kinetics and Mechanisms	1	511	November 27, 2025
N-Nitrosamine Formation in Pharmaceutical Drug Products: Development and Validation of a Biased, Conservative, Predictive Model-Pub NDSRI	4	404	November 24, 2025
Hunt for NDSRIs: Unveiling Hidden Threats with the Novel 15N-Enriched NAP Test-Pub NDSRI	1	274	November 20, 2025
In Vitro Metabolism Study of NDSRIs NDSRI	3	245	November 20, 2025
🇯🇵 Current Nitrosamine Landscape in Japan?	181	15787	November 19, 2025
Nitrosamine Contamination in Pharmaceuticals: A Retrospective Regulatory Analysis of USFDA Recalls and Risk Mitigation Strategies (2018–2025)-Pub FDA	0	201	November 18, 2025
N nitroso urapidil	0	72	November 18, 2025
FDA Announcement - Small Molecule Nitrosamines in Infusion Bags featured	12	2137	November 16, 2025
Nitrosamine Control: From Risk Assessment to Analytical Testing with Emphasis on Sample Preparation and Phase-Appropriate Method Validation-Pub	0	286	November 8, 2025
Construction of a modified Arrhenius equation for predicting drug nitrosation in solid dosage form -Pub featured	2	534	October 30, 2025
Peptide Synthesis - Does anyone have experience with potential Nitrosamine impurities coming from solid phase synthesis? Drug_Substance_APIs	1	181	October 16, 2025
Sample Prep for Complex Matrices - creams etc?	1	165	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	436	September 28, 2025
A Simple and Scalable Synthesis of N-Nitroso Salbutamol Impurities A, D, and F -Pub	1	128	September 27, 2025
Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation NDSRI , featured	18	4987	September 20, 2025
Nitrosamines risk in cleaning validation approach Live-Conversations , risk-assessment , Manufacturing , NDSRI	11	336	September 4, 2025
N-nitrosamines: in silico modelling of DNA reactivity and identification of metabolic precursors	0	159	August 12, 2025
Estimation of bioavailable concentration of endogenously formed N-nitrosamines by physiologically based kinetic modelling	1	143	August 7, 2025
Nitrosamine Formation with Lidocaine in Ointments and Injections	1	328	August 5, 2025
Synthesis of Nitroso Derivatives of Dihydropyridine Calcium Channel Blockers featured	5	470	July 31, 2025
Alignment between Duplex Sequencing and transgenic rodent mutation assay data in the assessment of in vivo NDMA-induced mutagenesis-Pub risk-assessment	0	142	July 21, 2025
Can anybody have scientific rationale about the non formation of N-nitroso-amlodipine	3	594	July 18, 2025
Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cells -Pub FDA , NDSRI	0	256	July 12, 2025
Analytical Method Development Strategy for Controlling Two New Nitrosamine Drug Substance Related Impurities (NDSRIs) in a Pharmaceutical Drug Product for Treatment of a Rare Disease -Pub NDSRI	0	107	June 25, 2025
N-Nitroso Phenylephrine and N-Nitroso Phenylephrone	1	221	June 25, 2025
Mitigation of N-Nitrosamine Formation in Ranitidine Hydrochloride by Spray Drying Co-Precipitation with Mannitol, Dextrin, and Antioxidant-Pub Manufacturing	0	123	June 21, 2025
Atmospheric Formation of Nitrosamines in Seoul, Korea	0	216	June 9, 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 …