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	1331	August 22, 2022
About the New Scientific Knowledge & Development category	0	411	April 14, 2021
Advantages and limitations of the inclusion of ascorbic acid on nitrosamine mitigation in pharmaceutical drug products-Pub Manufacturing	5	376	February 17, 2026
N-Nitroso methylphenidate anybody?	1	131	February 12, 2026
N-Nitroso Imidazole content in Clotrimazole	9	594	February 9, 2026
N-nitroso clonixin	3	121	February 6, 2026
🇯🇵 Current Nitrosamine Landscape in Japan?	182	16734	January 13, 2026
Hunt for NDSRIs: Unveiling Hidden Threats with the Novel 15N-Enriched NAP Test-Pub NDSRI	2	374	January 7, 2026
NDSRI in Pyrathiazine theocolate NDSRI	3	297	December 5, 2025
Role of Carbonyl Compounds for N-Nitrosamine Formation during Nitrosation: Kinetics and Mechanisms	1	534	November 27, 2025
N-Nitrosamine Formation in Pharmaceutical Drug Products: Development and Validation of a Biased, Conservative, Predictive Model-Pub NDSRI	4	444	November 24, 2025
In Vitro Metabolism Study of NDSRIs NDSRI	3	275	November 20, 2025
Nitrosamine Contamination in Pharmaceuticals: A Retrospective Regulatory Analysis of USFDA Recalls and Risk Mitigation Strategies (2018–2025)-Pub FDA	0	219	November 18, 2025
N nitroso urapidil	0	81	November 18, 2025
FDA Announcement - Small Molecule Nitrosamines in Infusion Bags featured	12	2326	November 16, 2025
Nitrosamine Control: From Risk Assessment to Analytical Testing with Emphasis on Sample Preparation and Phase-Appropriate Method Validation-Pub	0	317	November 8, 2025
Construction of a modified Arrhenius equation for predicting drug nitrosation in solid dosage form -Pub featured	2	678	October 30, 2025
Peptide Synthesis - Does anyone have experience with potential Nitrosamine impurities coming from solid phase synthesis? Drug_Substance_APIs	1	195	October 16, 2025
Sample Prep for Complex Matrices - creams etc?	1	179	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	472	September 28, 2025
A Simple and Scalable Synthesis of N-Nitroso Salbutamol Impurities A, D, and F -Pub	1	148	September 27, 2025
Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation NDSRI , featured	18	5110	September 20, 2025
Nitrosamines risk in cleaning validation approach Live-Conversations , risk-assessment , Manufacturing , NDSRI	11	365	September 4, 2025
N-nitrosamines: in silico modelling of DNA reactivity and identification of metabolic precursors	0	166	August 12, 2025
Estimation of bioavailable concentration of endogenously formed N-nitrosamines by physiologically based kinetic modelling	1	158	August 7, 2025
Nitrosamine Formation with Lidocaine in Ointments and Injections	1	377	August 5, 2025
Synthesis of Nitroso Derivatives of Dihydropyridine Calcium Channel Blockers featured	5	592	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	147	July 21, 2025
Can anybody have scientific rationale about the non formation of N-nitroso-amlodipine	3	644	July 18, 2025
Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cells -Pub FDA , NDSRI	0	268	July 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 …