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	527	August 22, 2022
About the New Scientific Knowledge & Development category	0	75	April 14, 2021
Computational Prediction of Metabolic α-Carbon Hydroxylation Potential of N-Nitrosamines: Overcoming Data Limitations for Carcinogenicity Assessment	5	328	March 23, 2023
Drawing a line: Where might the cohort of concern end? NDSRI	1	270	March 21, 2023
Current Nitrosamine Landscape in Japan?	49	1320	March 12, 2023
The Landscape of Small and Drug Substance Related Nitrosamines in Pharmaceuticals	10	724	March 8, 2023
U̶p̶c̶o̶m̶i̶n̶g̶ Nitrosamine Special Issue of JPS featured	3	684	March 7, 2023
Solid State Kinetics of Nitrosation Using Native Sources of Nitrite -Pub	1	162	March 6, 2023
EMA-funded project to predict in-vivo mutagenicity / mutagenicity classification	6	191	March 2, 2023
Current threat of nitrosamines in pharmaceuticals and scientific strategies for risk mitigation -Pub	0	250	February 7, 2023
2 years after pushing FDA to analyze Nitrosamines, Valisure cited it for failing to comply with federal law	3	162	February 15, 2023
Carry over limits for Niitrsoamines Manufacturing , Drug_Substance_APIs	2	179	February 12, 2023
N-Nitrosamine Formation in Pharmaceutical Solid Drug Products: Experimental Observations -Pub	0	418	February 7, 2023
A bioanalytical method for N-nitrosodimethylamine (NDMA) in human samples following ranitidine -Pub	0	110	February 7, 2023
Nitrosated active pharmaceutical ingredients – lessons learned -Pub	0	362	February 7, 2023
The impact of N-nitrosamine impurities on clinical drug development -Pub	1	316	February 3, 2023
Nitrosamine Impurities -Reg Updates Publication	0	239	February 1, 2023
An update on the current status of possible roots causes of Nitrosamines	2	483	January 28, 2023
N-nitrosamines considerations for Inhalation products	0	96	January 20, 2023
Crisis management of the mass losartan recall in a public primary healthcare institution in Singapore	0	91	January 9, 2023
FDA - A new structural similarity method to ID surrogate compounds of Nitroamines featured	5	604	January 7, 2023
A substructure-based screening approach to uncover Nnitrosamines in drug substances	0	261	October 10, 2022
Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines -published ames	0	159	September 8, 2022
Strategies for Assessing Acceptable Intakes for Novel N-Nitrosamines Derived from Active Pharmaceutical Ingredients Drug_Substance_APIs	3	203	November 30, 2022
NAs positive in Ames test without metabolic activation	2	118	November 29, 2022
A new study on nitrite scavengers for nitrosamine formation prevention	0	123	November 17, 2022
Predicting DNA-reactivity of N-nitrosamines: Quantum Chemical Approach	0	82	November 16, 2022
NitrosAMIDES - Should they be treated the same as Nitrosamines?	1	212	October 25, 2022
N-Nitrosamines: bacterial mutagenesis and in vitro metabolism -A MUST READ	6	223	October 13, 2022
N-Nitrosation in the absence of nitrosating agents in pharmaceuticals?	2	251	September 27, 2022

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 …