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Help/Information needed: Are bis-Aryl-Azoxy-compounds CoC or not?
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3
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175
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October 13, 2025
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Advancing Generic Drug Development: Translating Science to Approval 2025
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3
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439
|
October 10, 2025
|
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Sample Prep for Complex Matrices - creams etc?
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1
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181
|
October 10, 2025
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LTL Approach for New Generic Registrations
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5
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463
|
October 10, 2025
|
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EMA Q&A Rev. 22 (EMA/409815/2020 Rev.22)
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5
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2217
|
October 10, 2025
|
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Method Validation
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3
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179
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October 8, 2025
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Summary of Nitrosamines Exchange by ChatGPT (October 2025)
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4
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501
|
October 7, 2025
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Nitrosamines without published AI, and possibly negative for carcinogenicity
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11
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1315
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October 7, 2025
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🇺🇸 US FDA- Generic Drug Science and Research Priority Initiatives for Fiscal Year (FY) 2026
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0
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243
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October 6, 2025
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🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2
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65
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6032
|
October 3, 2025
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Use of recovery factor in nitrosamine analysis in drug product
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4
|
353
|
October 3, 2025
|
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US FDA- Generic Drug Science and Research Priority Initiatives for Fiscal Year (FY) 2024
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2
|
613
|
October 1, 2025
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Method of Analysis for N nitroso Diclofenac and Quetiapine
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14
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2616
|
October 1, 2025
|
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GC-VUV for nitrosamine qualification and quantification
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1
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151
|
September 30, 2025
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Monitoring the Concentration of Nitrogen Oxides in the Fluidized Bed Drying/Granulation Process and Evaluation of Reduction Methods
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2
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476
|
September 28, 2025
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A Simple and Scalable Synthesis of N-Nitroso Salbutamol Impurities A, D, and F -Pub
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1
|
149
|
September 27, 2025
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⚖️ Risk assessment not strong enough, specifically on related impurities containing secondary amine
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24
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2404
|
September 25, 2025
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👨💻 Quantitative Analysis of N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and -Nitroso-N-methyl-4-aminobutyric acid (NMBA) in Losartan Potassium Tablets by Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry
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1
|
351
|
September 24, 2025
|
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Quantitative genotoxicity assessment of N-nitrosodimethylamine in mice by error-corrected next-generation sequencing and DNA methylation quantification for toxicity threshold determination
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2
|
156
|
September 24, 2025
|
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N Nitroso Tadalfil
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5
|
576
|
September 23, 2025
|
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Analytical challenge for determination of instable standard of other N-nitroso structure
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|
10
|
778
|
September 22, 2025
|
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Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
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18
|
5134
|
September 20, 2025
|
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Nitrosamine CPCA
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|
5
|
374
|
September 18, 2025
|
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NDMA production in the presence of formaldehyde: Competition between acid-catalyzed and formaldehyde-catalyzed reactions
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|
8
|
514
|
September 17, 2025
|
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Estimation of genotoxic nitroso amines impurities in empagliflozin
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|
2
|
279
|
September 15, 2025
|
|
Alignment between Regulatory Agencies
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|
2
|
428
|
September 12, 2025
|
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Stability in risk assessment report
|
|
12
|
555
|
September 10, 2025
|
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Synthesis of N-Nitroso Finerenone
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|
7
|
590
|
September 9, 2025
|
|
Could gelatin contains amine functionalities, which react with nitrosating agents to form nirosamines?
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|
21
|
3082
|
September 4, 2025
|
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Nitrosamine mitigation through NOx absorption
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|
11
|
464
|
September 4, 2025
|