About the Limits of Nitrosamines category
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0
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958
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April 14, 2021
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Limits more than one Nitrosamine?
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40
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2442
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June 23, 2025
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Calculation of limit when more than one nitrosamine is identified
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10
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1103
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June 19, 2025
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Risk (Re)Assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine Drug Substance Related Impurities
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2
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147
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June 18, 2025
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Deriving safe limits for N-nitroso-bisoprolol by error-corrected next-generation sequencing (ecNGS) and benchmark dose (BMD) analysis, integrated with QM modeling and CYP-docking analysis
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7
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327
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June 18, 2025
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Using N-Nitrosodiethanolamine (NDELA) and N-Nitrosopiperidine (NPIP) Transgenic Rodent Gene Mutation Data and Quantum Mechanical Modeling to Derive Potency-Based Acceptable Intakes for NDSRIs Lacking Robust Carcinogenicity Data-Pub
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0
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169
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June 6, 2025
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AI limit for 1-Nitrosopiperazine
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8
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263
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June 4, 2025
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EMA - Appendix 1 - Update
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57
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5070
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May 30, 2025
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Limits for NDMA in Dapagliflozin+Metformin
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19
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384
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May 28, 2025
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If only I had known…
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41
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1953
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May 23, 2025
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How to set Acceptance criteria for nitrosamines impurities in FDC-FPPs
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1
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145
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May 6, 2025
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N-nitroso-Impurity C in Metamizol Drug product
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16
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1905
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May 6, 2025
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MDD for Metformin
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4
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234
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May 2, 2025
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:australia: TGA - Latest Update to Nitrosamine Limits
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8
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1738
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May 2, 2025
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Risk Assessment ASS/Paracetamol/Coffein tablets
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7
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521
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April 29, 2025
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Visualization of Categorized Compounds by CPCA
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67
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8535
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April 24, 2025
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N-nitroso-esmolol
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0
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98
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April 22, 2025
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⁉️ Duloxetine Impurity NDSRI
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9
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906
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April 22, 2025
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The quagmire with the interim limit of nitroso duloxetine
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6
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543
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April 21, 2025
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N-nitroso-amlodipine ; N-nitroso-felodipine ; synthesis not successfull but still listed by FDA and EMA as NDSRIs
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15
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4073
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April 16, 2025
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LTL or not LTL that's the question?
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5
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425
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April 15, 2025
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N-Nitroso Caffeidine
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3
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115
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April 14, 2025
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Risk mitigation based on DP specifications
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10
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602
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April 7, 2025
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Evaluation of the nitrosamine impurities of ACE inhibitors using computational, in vitro, and in vivo methods demonstrate no genotoxic potential -Pub
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8
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523
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April 2, 2025
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N-nitrosodicyclohexylamine (NDCHA), what do you know about it?
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18
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480
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March 21, 2025
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AI limits and CPCA score (O=NN1CCN=C1CCl)
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8
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364
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March 17, 2025
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Draft guidance on the use of read across for chemical safety assessment in food and feed(EFSA)
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0
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230
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March 16, 2025
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Is there any possibility to generate the N-Desmethyl Tramadol in formulation?
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5
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461
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March 11, 2025
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Nitrosamine Calculation in Sita + Met Tablets
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8
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450
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March 11, 2025
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Nitrosamine Calculation for FDC
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0
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167
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March 8, 2025
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