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	1258	August 22, 2022
About the New Scientific Knowledge & Development category	0	404	April 14, 2021
AMES Test Study Designs for Nitrosamine Mutagenicity Testing -Pub	11	1261	April 18, 2025
N-Nitroso clozapine	2	178	April 3, 2025
Laboratory Study in Gastric Nitrosamine Formation	8	363	April 2, 2025
🇯🇵 Current Nitrosamine Landscape in Japan?	140	12927	April 1, 2025
New publication on "Nitrosation" from MultiCASE	7	469	March 29, 2025
Industrial Case Studies Demonstrating Applicability of ICH M7Control Options 3 and 4 for Nitrosamine Control -Pub ICH-M7	3	454	March 26, 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	249	March 24, 2025
N-nitroso Torasemide Impurity formation and control Drug_Substance_APIs , NDSRI	27	2102	March 9, 2025
📓 Special Issue of OPRD - Analytical Control Strategies for Process Chemists	0	157	February 27, 2025
Nitrosation and Degradations Reaction Predictions and Limit Calculations Packaging	1	554	February 25, 2025
Impact of Antioxidant Excipients on N-nitrosamine Formation and Bioequivalence in Metformin Formulations - Pub risk-assessment , Excipients , FDA	3	545	February 11, 2025
Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation NDSRI , featured	17	4212	January 10, 2025
Rat Liver Micronucleus Assay as a Nitrosamine Potency Assessment	1	192	January 8, 2025
Metformin and nitrosation of guanidines	3	224	December 18, 2024
Exploration for Chemical Filter Cartridges that Can Reduce Nitrogen Oxides, a Common Factor in the Formation of Nitrosamines risk-assessment , Manufacturing	0	193	December 15, 2024
Requirement after reformulation of existing approved drug product for Europe EMA , FDA	12	379	November 12, 2024
Resolution of Historically Discordant Ames Test Negative / Rodent Carcinogenicity Positive N-nitrosamines using a Sensitive, OECD-aligned Design-Pub	0	235	November 2, 2024
Nitrosamine Mitigation Case Study	6	402	October 31, 2024
N-Nitroso Desmethyl Tramadol NDSRI	3	457	October 29, 2024
Software for prediction of NDSRI generation NDSRI	5	576	October 24, 2024
Optimizing the detection of N-nitrosamine mutagenicity in the Ames test -Pub NDSRI	16	562	October 21, 2024
Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide impurity formation and its inhibition in bumetanide tablets -Pub	7	1137	October 19, 2024
Nitrosamine mitigation: NDMA impurity formation and its inhibition in metformin hydrochloride tablets -Pub FDA	2	178	October 15, 2024
Reactivities of N-Nitrosamines against Common Reagents and Reaction Conditions -Pub	2	315	October 15, 2024
Selection of Solvent and Positive Control Concentration for Enhanced Ames Test Conditions for N-Nitrosamine Compounds -Pub	0	147	October 11, 2024
N-Nitrosamines: bacterial mutagenesis and in vitro metabolism -A MUST READ	9	779	October 10, 2024
Dynamics of Nitroso-STG-19 entering the blood circulation NDSRI	1	125	October 10, 2024
Aptar’s N-Sorb Nitrosamine Mitigation Solution Accepted to US FDA’s Emerging Technology Program Packaging , FDA	6	446	October 2, 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 …