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Chemistry of N-Nitroso Ivacaftor
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7
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965
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December 18, 2024
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EMA nitrosamine Q&A Appendix 1 rev.7 published on Dec 13, 2024
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6
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367
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December 16, 2024
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Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific Acceptable Intakes-Pub
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5
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246
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December 16, 2024
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N-nitroso-Duloxetine recall back in the news!
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12
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1962
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December 13, 2024
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Limit of N-nitroso morpholine in Rocuronium Br
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0
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48
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December 12, 2024
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Autonomous CPCA Web-based calculator FREE
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31
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5256
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December 12, 2024
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📅 Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products(CRCG)
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35
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2779
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December 3, 2024
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N-Nitroso Sertraline
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7
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307
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November 27, 2024
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🛑 N-nitroso Ticagrelor
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12
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2789
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October 25, 2024
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N-Nitroso Metoprolol
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0
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103
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November 20, 2024
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Analytical procedure development and proposed established conditions: A case study of a mass spectrometry based NDSRI analytical procedure -Pub
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19
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1602
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November 6, 2024
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⁉️ Duloxetine Impurity NDSRI
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7
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629
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November 1, 2024
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Hypothetical Nitrosamine in 1-H Indazole / CPCA Approach
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3
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116
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October 31, 2024
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📅 Analytical challenges and the effective management of nitrosamines: The evolving landscape of NDSRI analysis
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3
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474
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October 30, 2024
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What is CPCA Score for “N-nitroso of 3-Amino-1,2,4-triazole"
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5
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211
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October 30, 2024
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N-Nitroso Desmethyl Tramadol
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3
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284
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October 29, 2024
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Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA) -Pub
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0
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138
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October 29, 2024
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Hexamethyldisilazane (HMDS) can form Nitrosamine Impurity?
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7
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494
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October 29, 2024
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N-Nitrosamine drug substance related impurities (NDSRIs) – A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da -Pub
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0
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190
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October 28, 2024
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Software for prediction of NDSRI generation
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5
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501
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October 24, 2024
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N-Nitroso duloxetine methods from SwissMedic and Taiwan FDA
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0
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102
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October 24, 2024
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Nationwide recall of duloxetine
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0
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211
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October 23, 2024
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Optimizing the detection of N-nitrosamine mutagenicity in the Ames test -Pub
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16
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454
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October 21, 2024
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Dynamics of Nitroso-STG-19 entering the blood circulation
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1
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120
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October 10, 2024
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🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments
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5
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1625
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October 9, 2024
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Case Studies for CPCA Scoring
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18
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4040
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September 30, 2024
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🖩 CPCA Calculation Tool (excel-based) -Updated
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87
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10750
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September 27, 2024
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Multiple Secondary Amine Groups in the Same Molecule
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2
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210
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September 26, 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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205
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September 18, 2024
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Potential Topic for an event concerning obtaining the right level of Nitrosamine Risk Assessment information from your CMOs
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23
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1615
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September 8, 2024
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