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	1286	August 22, 2022
About the New Scientific Knowledge & Development category	0	406	April 14, 2021
🇯🇵 Current Nitrosamine Landscape in Japan?	178	15076	September 8, 2025
Nitrosamines risk in cleaning validation approach Live-Conversations , risk-assessment , Manufacturing , NDSRI	11	238	September 4, 2025
FDA Announcement - Small Molecule Nitrosamines in Infusion Bags featured	9	1208	August 26, 2025
N-nitrosamines: in silico modelling of DNA reactivity and identification of metabolic precursors	0	148	August 12, 2025
Estimation of bioavailable concentration of endogenously formed N-nitrosamines by physiologically based kinetic modelling	1	131	August 7, 2025
Nitrosamine Formation with Lidocaine in Ointments and Injections	1	236	August 5, 2025
Synthesis of Nitroso Derivatives of Dihydropyridine Calcium Channel Blockers featured	5	322	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	114	July 21, 2025
Can anybody have scientific rationale about the non formation of N-nitroso-amlodipine	3	425	July 18, 2025
Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cells -Pub FDA , NDSRI	0	243	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	74	June 25, 2025
N-Nitroso Phenylephrine and N-Nitroso Phenylephrone	1	148	June 25, 2025
Mitigation of N-Nitrosamine Formation in Ranitidine Hydrochloride by Spray Drying Co-Precipitation with Mannitol, Dextrin, and Antioxidant-Pub Manufacturing	0	107	June 21, 2025
Atmospheric Formation of Nitrosamines in Seoul, Korea	0	193	June 9, 2025
New Paper: Impact of antioxidant addition on drug dissolution: Implications for NDSRI mitigation biowaivers	1	261	June 5, 2025
Comparative DNA damage induced by 8 nitrosamines in primary human and macaque hepatocytes -Pub mutagenicity , carconogenicity , safety	1	119	May 27, 2025
N-nitroso Torasemide Impurity formation and control Drug_Substance_APIs , NDSRI	33	2342	May 27, 2025
Optimizing the detection of N-nitrosamine mutagenicity in the Ames test -Pub NDSRI	17	705	May 23, 2025
Metformin and nitrosation of guanidines	8	403	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	356	May 17, 2025
Nitrate and nitrite food composition database: an update and extensive deep dive	2	289	May 14, 2025
HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions -Pub ames , safety	0	107	May 13, 2025
NitrosAMIDES - Should they be treated the same as Nitrosamines?	3	968	May 7, 2025
Understanding Aqueous Nitrosation Kinetics of 4-Substituted Piperidines To Risk Assess Pharmaceutical Processes and Products-Pub NDSRI	1	162	May 6, 2025
Interferencia de matriz para cuantificación de NDBA Excipients	0	72	May 5, 2025
🇰🇷 Korea NRA on 'Case Studies on Reducing Impurities in Pharmaceuticals (focusing on NDMA)" Drug_Substance_APIs , ndma	0	313	May 1, 2025
Industrial Case Studies Demonstrating Applicability of ICH M7Control Options 3 and 4 for Nitrosamine Control -Pub ICH-M7	4	638	April 22, 2025
Published Article: Tale of Three N-Nitrosamines and the Variables Needed to Assess Their Carcinogenicity In Silico Incorporated into a Single Workflow	0	179	April 22, 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 …