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Nitrosamine mitigation: NDMA impurity formation and its inhibition in metformin hydrochloride tablets -Pub FDA
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2
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182
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October 15, 2024
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Reactivities of N-Nitrosamines against Common Reagents and Reaction Conditions -Pub
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2
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316
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October 15, 2024
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Selection of Solvent and Positive Control Concentration for Enhanced Ames Test Conditions for N-Nitrosamine Compounds -Pub
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0
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153
|
October 11, 2024
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N-Nitrosamines: bacterial mutagenesis and in vitro metabolism -A MUST READ
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9
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782
|
October 10, 2024
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Dynamics of Nitroso-STG-19 entering the blood circulation
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1
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125
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October 10, 2024
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Aptar’s N-Sorb Nitrosamine Mitigation Solution Accepted to US FDA’s Emerging Technology Program
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6
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456
|
October 2, 2024
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New paper - Use of molar, instead of weight-based, safety limits
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17
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2846
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September 25, 2024
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🙋♂️ Citizen Petition to FDA on Sitagliptin
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21
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3526
|
June 7, 2024
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Escaping the cohort of concern: in vitro experimental evidence supports non-mutagenicity of N-nitroso-hydrochlorothiazide -Pub
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1
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224
|
September 18, 2024
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Can API with amide should considered a potential candidate for forming nitrosamine impurity
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5
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395
|
September 12, 2024
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Synthesis and mutagenic risk of avanafil's potential genotoxic impurities -Pub
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0
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110
|
August 25, 2024
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Gut Microbiotica Carcinogen Metabolism - Nitrosamines
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5
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178
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August 7, 2024
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Strategy to Assess and Control Nitrosamine Formation in API during Storage: A Sitagliptin Case Study
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0
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362
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August 6, 2024
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N-Nitroso Imidazole content in Clotrimazole
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4
|
300
|
August 5, 2024
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N-nitroso Tamsulosin identification in Tamsulosin Products by LC-MS/MS
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0
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261
|
August 1, 2024
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Risk Evaluation of N-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody–Drug Conjugates -Pub
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2
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262
|
July 31, 2024
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Valsartan, Losartan and Irbesartan use in the USA, UK, Canada and Denmark after the nitrosamine recalls: a descriptive cohort study -Pub
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1
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247
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July 31, 2024
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Kinetic Model for Assessing Potential Nitrosamine Carcinogenicity
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1
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146
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July 30, 2024
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Using the relative potency comparison approach, Powley et al have demonstrated the safety of NTTP exposures at or above levels of 1500 ng/day
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1
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267
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July 30, 2024
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Nitrosamine Contamination of Pharmaceuticals: Cases in Japan, Formation Mechanisms, Detection Methods, Regulatory Perspectives, and Insights -Pub
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1
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178
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July 30, 2024
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How to overcome the challenges of manual read-across when assessing nitrosamine acceptable intake limits
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0
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130
|
July 26, 2024
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Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies -Pub
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0
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557
|
July 23, 2024
|
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Quantum Mechanical Assessment of Nitrosamine Potency -Pub
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3
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445
|
July 15, 2024
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AZIDO Impurities Topic
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4
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1296
|
July 11, 2024
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A Case to Support the Continued Use of Rifampin in Clinical Drug–Drug Interaction Studies -Pub
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0
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171
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July 10, 2024
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Non-mutagenic, carcinogenic impurities
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3
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554
|
June 30, 2024
|
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Discussion on Cleaning Validation Requirements for Nitrosamines
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3
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1047
|
June 24, 2024
|
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On the role of digital tools in nitrosamine risk assessment for drug substance and drug product manufacturing processes -Pub
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0
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203
|
June 13, 2024
|
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EMA-funded project to predict in-vivo mutagenicity / mutagenicity classification
|
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9
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1047
|
June 11, 2024
|
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A new root cause? NOx
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13
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1928
|
November 17, 2023
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