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	813	August 22, 2022
About the New Scientific Knowledge & Development category	0	239	April 14, 2021
Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation NDSRI , featured	2	672	November 27, 2023
New paper - Use of molar, instead of weight-based, safety limits	7	997	November 23, 2023
New data released into Lhasa Carcinogenicity Database	1	278	November 17, 2023
A new root cause? NOx	13	706	November 17, 2023
Why do some mutagenic N-nitrosamines not require metabolic activation?	0	121	November 15, 2023
Review of NDSRIs in Pharmaceutical Drugs -Pub featured , NDSRI	1	323	November 13, 2023
📚 OPRD Special Issue on Nitrosamines -Pub featured	11	954	November 8, 2023
Current Nitrosamine Landscape in Japan?	76	4368	November 6, 2023
Does atmospheric NO2 influence the formation of NDMA in metformin? Drug_Substance_APIs	2	256	November 3, 2023
Not all Nitro structures are Nitrosamines!	1	354	November 2, 2023
🙋‍♂️ Citizen Petition to FDA on Sitagliptin	18	1180	November 1, 2023
Redefining Nitrosamine Risks: A Fresh Perspective on Pharmaceuticals -Pub Drug_Substance_APIs , NDSRI , featured	15	1072	October 25, 2023
Developing Structure-Activity Relationships for N-Nitrosamine Activity	7	418	October 13, 2023
N-nitroso Torasemide Impurity formation and control Drug_Substance_APIs , NDSRI	14	583	September 26, 2023
Nitrosamines in Biologics	1	273	September 18, 2023
Nitrite Detection at Picogram Level, is it possible? Drug_Substance_APIs	4	539	September 14, 2023
Identifying the Risk of Formation of Nitrosamines and Other Potentially Mutagenic Impurities during API Manufacture Using In Silico Risk Assessment -Pub risk-assessment	0	890	June 6, 2023
A deep dive into historical Ames study data for N-nitrosamine compounds -Pub	0	212	September 8, 2023
A nitrosamine twist	0	235	August 24, 2023
Strategies for Assessing Acceptable Intakes for Novel N-Nitrosamines Derived from Active Pharmaceutical Ingredients Drug_Substance_APIs	4	474	August 23, 2023
Approaches and Considerations for the Investigation and Synthesis of N‑Nitrosamine Drug Substance-Related Impurities (NDSRIs) NDSRI	0	305	August 23, 2023
Maximizing use of existing carcinogenicity data to support AI levels -Pub	0	207	July 31, 2023
Genotoxicity Assessment using HepaRG Models	2	193	July 28, 2023
Forced degradation: predicting nitrosamine formation NDSRI , Drug_Substance_APIs	8	865	July 20, 2023
Acceptable Intakes (AIs) for 11 Small molecule N-nitrosamines (NAs) -Pub	10	1231	July 19, 2023
Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide impurity formation and its inhibition in bumetanide tablets -Pub	0	411	June 27, 2023
Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities (NDSRIs) NDSRI	1	510	May 31, 2023
Impact of N‑nitrosamines presence and ARB recall on ARB utilization – results from IQVIA™ Disease Analyzer	1	281	May 2, 2023

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 …