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	1271	August 22, 2022
About the New Scientific Knowledge & Development category	0	405	April 14, 2021
🇯🇵 Current Nitrosamine Landscape in Japan?	150	13414	June 3, 2025
Comparative DNA damage induced by 8 nitrosamines in primary human and macaque hepatocytes -Pub mutagenicity , carconogenicity , safety	1	108	May 27, 2025
N-nitroso Torasemide Impurity formation and control Drug_Substance_APIs , NDSRI	33	2259	May 27, 2025
Optimizing the detection of N-nitrosamine mutagenicity in the Ames test -Pub NDSRI	17	645	May 23, 2025
Metformin and nitrosation of guanidines	8	371	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	337	May 17, 2025
Nitrate and nitrite food composition database: an update and extensive deep dive	2	267	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	96	May 13, 2025
NitrosAMIDES - Should they be treated the same as Nitrosamines?	3	939	May 7, 2025
Understanding Aqueous Nitrosation Kinetics of 4-Substituted Piperidines To Risk Assess Pharmaceutical Processes and Products-Pub NDSRI	1	134	May 6, 2025
Interferencia de matriz para cuantificación de NDBA Excipients	0	65	May 5, 2025
🇰🇷 Korea NRA on 'Case Studies on Reducing Impurities in Pharmaceuticals (focusing on NDMA)" Drug_Substance_APIs , ndma	0	285	May 1, 2025
Industrial Case Studies Demonstrating Applicability of ICH M7Control Options 3 and 4 for Nitrosamine Control -Pub ICH-M7	4	577	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	167	April 22, 2025
AMES Test Study Designs for Nitrosamine Mutagenicity Testing -Pub	11	1319	April 18, 2025
N-Nitroso clozapine	2	189	April 3, 2025
Laboratory Study in Gastric Nitrosamine Formation	8	377	April 2, 2025
New publication on "Nitrosation" from MultiCASE	7	488	March 29, 2025
Quantitative Investigation of Nitrosamine Drug Substance-Related Impurities (NDSRIs) Under Artificial Gastric Conditions by Liquid Chromatography–Tandem Mass Spectrometry and Structure–Activity Relationship Analysis -Pub NDSRI	0	263	March 24, 2025
📓 Special Issue of OPRD - Analytical Control Strategies for Process Chemists	0	164	February 27, 2025
Nitrosation and Degradations Reaction Predictions and Limit Calculations Packaging	1	567	February 25, 2025
Impact of Antioxidant Excipients on N-nitrosamine Formation and Bioequivalence in Metformin Formulations - Pub risk-assessment , Excipients , FDA	3	582	February 11, 2025
Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation NDSRI , featured	17	4393	January 10, 2025
Rat Liver Micronucleus Assay as a Nitrosamine Potency Assessment	1	197	January 8, 2025
Exploration for Chemical Filter Cartridges that Can Reduce Nitrogen Oxides, a Common Factor in the Formation of Nitrosamines risk-assessment , Manufacturing	0	216	December 15, 2024
Requirement after reformulation of existing approved drug product for Europe EMA , FDA	12	393	November 12, 2024
Resolution of Historically Discordant Ames Test Negative / Rodent Carcinogenicity Positive N-nitrosamines using a Sensitive, OECD-aligned Design-Pub	0	238	November 2, 2024
Nitrosamine Mitigation Case Study	6	415	October 31, 2024

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 …