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	1177	August 22, 2022
About the New Scientific Knowledge & Development category	0	396	April 14, 2021
New paper - solvents for EAT (NDMA and CPNP study)	0	47	October 11, 2024
N-Nitrosamines: bacterial mutagenesis and in vitro metabolism -A MUST READ	9	735	October 10, 2024
Dynamics of Nitroso-STG-19 entering the blood circulation NDSRI	1	98	October 10, 2024
Optimizing the detection of N-nitrosamine mutagenicity in the Ames test -Pub NDSRI	14	287	October 3, 2024
Aptar’s N-Sorb Nitrosamine Mitigation Solution Accepted to US FDA’s Emerging Technology Program Packaging , FDA	6	370	October 2, 2024
New paper - Use of molar, instead of weight-based, safety limits	17	2627	September 25, 2024
N-Nitroso Desmethyl Tramadol NDSRI	0	132	September 25, 2024
🙋‍♂️ Citizen Petition to FDA on Sitagliptin	28	3449	September 21, 2024
🇯🇵 Current Nitrosamine Landscape in Japan?	123	11380	September 21, 2024
Reactivities of N-Nitrosamines against Common Reagents and Reaction Conditions -Pub	1	217	September 19, 2024
Escaping the cohort of concern: in vitro experimental evidence supports non-mutagenicity of N-nitroso-hydrochlorothiazide -Pub NDSRI	1	195	September 18, 2024
Can API with amide should considered a potential candidate for forming nitrosamine impurity Drug_Substance_APIs	5	218	September 12, 2024
Synthesis and mutagenic risk of avanafil's potential genotoxic impurities -Pub ICH-M7	0	77	August 25, 2024
AMES Test Study Designs for Nitrosamine Mutagenicity Testing -Pub	10	1148	August 13, 2024
Gut Microbiotica Carcinogen Metabolism - Nitrosamines	5	166	August 7, 2024
Strategy to Assess and Control Nitrosamine Formation in API during Storage: A Sitagliptin Case Study NDSRI	0	278	August 6, 2024
N-Nitroso Imidazole content in Clotrimazole	4	242	August 5, 2024
N-nitroso Tamsulosin identification in Tamsulosin Products by LC-MS/MS	1	216	August 2, 2024
Risk Evaluation of N-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody–Drug Conjugates -Pub	2	226	July 31, 2024
Valsartan, Losartan and Irbesartan use in the USA, UK, Canada and Denmark after the nitrosamine recalls: a descriptive cohort study -Pub Valsartan	1	190	July 31, 2024
Kinetic Model for Assessing Potential Nitrosamine Carcinogenicity	1	127	July 30, 2024
Using the relative potency comparison approach, Powley et al have demonstrated the safety of NTTP exposures at or above levels of 1500 ng/day	1	235	July 30, 2024
Nitrosamine Contamination of Pharmaceuticals: Cases in Japan, Formation Mechanisms, Detection Methods, Regulatory Perspectives, and Insights -Pub	1	143	July 30, 2024
How to overcome the challenges of manual read-across when assessing nitrosamine acceptable intake limits NDSRI	0	119	July 26, 2024
Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies -Pub ICH-M7	0	510	July 23, 2024
Quantum Mechanical Assessment of Nitrosamine Potency -Pub	3	409	July 15, 2024
AZIDO Impurities Topic	4	1218	July 11, 2024
A Case to Support the Continued Use of Rifampin in Clinical Drug–Drug Interaction Studies -Pub rifampin	0	163	July 10, 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 …