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	1273	August 22, 2022
About the New Scientific Knowledge & Development category	0	405	April 14, 2021
Atmospheric Formation of Nitrosamines in Seoul, Korea	0	144	June 9, 2025
New Paper: Impact of antioxidant addition on drug dissolution: Implications for NDSRI mitigation biowaivers	1	196	June 5, 2025
🇯🇵 Current Nitrosamine Landscape in Japan?	151	13558	June 3, 2025
Comparative DNA damage induced by 8 nitrosamines in primary human and macaque hepatocytes -Pub mutagenicity , carconogenicity , safety	1	112	May 27, 2025
N-nitroso Torasemide Impurity formation and control Drug_Substance_APIs , NDSRI	33	2282	May 27, 2025
Optimizing the detection of N-nitrosamine mutagenicity in the Ames test -Pub NDSRI	17	653	May 23, 2025
Metformin and nitrosation of guanidines	8	374	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	341	May 17, 2025
Nitrate and nitrite food composition database: an update and extensive deep dive	2	269	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	98	May 13, 2025
NitrosAMIDES - Should they be treated the same as Nitrosamines?	3	948	May 7, 2025
Understanding Aqueous Nitrosation Kinetics of 4-Substituted Piperidines To Risk Assess Pharmaceutical Processes and Products-Pub NDSRI	1	139	May 6, 2025
Interferencia de matriz para cuantificación de NDBA Excipients	0	66	May 5, 2025
🇰🇷 Korea NRA on 'Case Studies on Reducing Impurities in Pharmaceuticals (focusing on NDMA)" Drug_Substance_APIs , ndma	0	292	May 1, 2025
Industrial Case Studies Demonstrating Applicability of ICH M7Control Options 3 and 4 for Nitrosamine Control -Pub ICH-M7	4	593	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	169	April 22, 2025
AMES Test Study Designs for Nitrosamine Mutagenicity Testing -Pub	11	1321	April 18, 2025
N-Nitroso clozapine	2	195	April 3, 2025
Laboratory Study in Gastric Nitrosamine Formation	8	377	April 2, 2025
New publication on "Nitrosation" from MultiCASE	7	496	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	268	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	569	February 25, 2025
Impact of Antioxidant Excipients on N-nitrosamine Formation and Bioequivalence in Metformin Formulations - Pub risk-assessment , Excipients , FDA	3	594	February 11, 2025
Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation NDSRI , featured	17	4420	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	221	December 15, 2024
Requirement after reformulation of existing approved drug product for Europe EMA , FDA	12	394	November 12, 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 …