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	1302	August 22, 2022
About the New Scientific Knowledge & Development category	0	406	April 14, 2021
FDA Announcement - Small Molecule Nitrosamines in Infusion Bags featured	12	1907	November 16, 2025
Hunt for NDSRIs: Unveiling Hidden Threats with the Novel 15N-Enriched NAP Test-Pub NDSRI	0	26	November 15, 2025
Nitrosamine Control: From Risk Assessment to Analytical Testing with Emphasis on Sample Preparation and Phase-Appropriate Method Validation-Pub	0	233	November 8, 2025
Construction of a modified Arrhenius equation for predicting drug nitrosation in solid dosage form -Pub featured	2	460	October 30, 2025
🇯🇵 Current Nitrosamine Landscape in Japan?	180	15522	October 21, 2025
Peptide Synthesis - Does anyone have experience with potential Nitrosamine impurities coming from solid phase synthesis? Drug_Substance_APIs	1	169	October 16, 2025
Sample Prep for Complex Matrices - creams etc?	1	160	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	403	September 28, 2025
A Simple and Scalable Synthesis of N-Nitroso Salbutamol Impurities A, D, and F -Pub	1	122	September 27, 2025
Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation NDSRI , featured	18	4897	September 20, 2025
Nitrosamines risk in cleaning validation approach Live-Conversations , risk-assessment , Manufacturing , NDSRI	11	320	September 4, 2025
N-nitrosamines: in silico modelling of DNA reactivity and identification of metabolic precursors	0	155	August 12, 2025
Estimation of bioavailable concentration of endogenously formed N-nitrosamines by physiologically based kinetic modelling	1	135	August 7, 2025
Nitrosamine Formation with Lidocaine in Ointments and Injections	1	301	August 5, 2025
Synthesis of Nitroso Derivatives of Dihydropyridine Calcium Channel Blockers featured	5	424	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	136	July 21, 2025
Can anybody have scientific rationale about the non formation of N-nitroso-amlodipine	3	550	July 18, 2025
Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cells -Pub FDA , NDSRI	0	252	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	92	June 25, 2025
N-Nitroso Phenylephrine and N-Nitroso Phenylephrone	1	200	June 25, 2025
Mitigation of N-Nitrosamine Formation in Ranitidine Hydrochloride by Spray Drying Co-Precipitation with Mannitol, Dextrin, and Antioxidant-Pub Manufacturing	0	113	June 21, 2025
Atmospheric Formation of Nitrosamines in Seoul, Korea	0	208	June 9, 2025
New Paper: Impact of antioxidant addition on drug dissolution: Implications for NDSRI mitigation biowaivers	1	277	June 5, 2025
Comparative DNA damage induced by 8 nitrosamines in primary human and macaque hepatocytes -Pub mutagenicity , carconogenicity , safety	1	123	May 27, 2025
N-nitroso Torasemide Impurity formation and control Drug_Substance_APIs , NDSRI	33	2392	May 27, 2025
Optimizing the detection of N-nitrosamine mutagenicity in the Ames test -Pub NDSRI	17	738	May 23, 2025
Metformin and nitrosation of guanidines	8	435	May 21, 2025
Using the relative potency comparison approach, Powley et al have demonstrated the safety of NTTP exposures at or above levels of 1500 ng/day	2	364	May 17, 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 …