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	1223	August 22, 2022
About the New Scientific Knowledge & Development category	0	400	April 14, 2021
🇯🇵 Current Nitrosamine Landscape in Japan?	129	12069	January 17, 2025
Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation NDSRI , featured	17	3716	January 10, 2025
Rat Liver Micronucleus Assay as a Nitrosamine Potency Assessment	1	174	January 8, 2025
Metformin and nitrosation of guanidines	3	190	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	153	December 15, 2024
Requirement after reformulation of existing approved drug product for Europe EMA , FDA	12	359	November 12, 2024
Resolution of Historically Discordant Ames Test Negative / Rodent Carcinogenicity Positive N-nitrosamines using a Sensitive, OECD-aligned Design-Pub	0	220	November 2, 2024
Nitrosamine Mitigation Case Study	6	368	October 31, 2024
N-Nitroso Desmethyl Tramadol NDSRI	3	313	October 29, 2024
Laboratory Study in Gastric Nitrosamine Formation	1	137	October 24, 2024
Software for prediction of NDSRI generation NDSRI	5	526	October 24, 2024
Optimizing the detection of N-nitrosamine mutagenicity in the Ames test -Pub NDSRI	16	482	October 21, 2024
Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide impurity formation and its inhibition in bumetanide tablets -Pub	7	1113	October 19, 2024
Nitrosamine mitigation: NDMA impurity formation and its inhibition in metformin hydrochloride tablets -Pub FDA	2	159	October 15, 2024
Reactivities of N-Nitrosamines against Common Reagents and Reaction Conditions -Pub	2	295	October 15, 2024
Selection of Solvent and Positive Control Concentration for Enhanced Ames Test Conditions for N-Nitrosamine Compounds -Pub	0	134	October 11, 2024
N-Nitrosamines: bacterial mutagenesis and in vitro metabolism -A MUST READ	9	768	October 10, 2024
Dynamics of Nitroso-STG-19 entering the blood circulation NDSRI	1	121	October 10, 2024
Aptar’s N-Sorb Nitrosamine Mitigation Solution Accepted to US FDA’s Emerging Technology Program Packaging , FDA	6	423	October 2, 2024
New paper - Use of molar, instead of weight-based, safety limits	17	2730	September 25, 2024
🙋‍♂️ Citizen Petition to FDA on Sitagliptin	21	3479	June 7, 2024
Escaping the cohort of concern: in vitro experimental evidence supports non-mutagenicity of N-nitroso-hydrochlorothiazide -Pub NDSRI	1	211	September 18, 2024
Can API with amide should considered a potential candidate for forming nitrosamine impurity Drug_Substance_APIs	5	292	September 12, 2024
Synthesis and mutagenic risk of avanafil's potential genotoxic impurities -Pub ICH-M7	0	96	August 25, 2024
AMES Test Study Designs for Nitrosamine Mutagenicity Testing -Pub	10	1197	August 13, 2024
Gut Microbiotica Carcinogen Metabolism - Nitrosamines	5	176	August 7, 2024
Strategy to Assess and Control Nitrosamine Formation in API during Storage: A Sitagliptin Case Study NDSRI	0	318	August 6, 2024
N-Nitroso Imidazole content in Clotrimazole	4	268	August 5, 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 …