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About the Limits of Nitrosamines category
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0
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974
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April 14, 2021
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Published limit for N-Nitroso-Vonoprazan
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2
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146
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August 15, 2025
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N-nitroso-Impurity C in Metamizol Drug product
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22
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2144
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August 13, 2025
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EMA has updated its AI limits on 01 Aug 2025
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7
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688
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August 11, 2025
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:australia: TGA - Latest Update to Nitrosamine Limits
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9
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1946
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July 31, 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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4324
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April 16, 2025
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Lifetime Cumulative Dose and Less Than Lifetime Approach
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3
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466
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July 16, 2025
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MEGLUMINE (Methylglucamine)
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27
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3087
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July 10, 2025
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Criterios de aceptación
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2
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85
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June 26, 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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10
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460
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June 26, 2025
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Limits more than one Nitrosamine?
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44
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2692
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June 26, 2025
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Quantifier and Qualifier Ion in mass spec
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6
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170
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June 26, 2025
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Calculation of limit when more than one nitrosamine is identified
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10
|
1168
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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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198
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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
|
197
|
June 6, 2025
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AI limit for 1-Nitrosopiperazine
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8
|
354
|
June 4, 2025
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EMA - Appendix 1 - Update
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57
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5369
|
May 30, 2025
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Limits for NDMA in Dapagliflozin+Metformin
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19
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425
|
May 28, 2025
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If only I had known…
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41
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1997
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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
|
168
|
May 6, 2025
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MDD for Metformin
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4
|
245
|
May 2, 2025
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Risk Assessment ASS/Paracetamol/Coffein tablets
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7
|
592
|
April 29, 2025
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Visualization of Categorized Compounds by CPCA
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67
|
8624
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April 24, 2025
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N-nitroso-esmolol
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0
|
122
|
April 22, 2025
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⁉️ Duloxetine Impurity NDSRI
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9
|
930
|
April 22, 2025
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The quagmire with the interim limit of nitroso duloxetine
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6
|
558
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April 21, 2025
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LTL or not LTL that's the question?
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5
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431
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April 15, 2025
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N-Nitroso Caffeidine
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3
|
121
|
April 14, 2025
|
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Risk mitigation based on DP specifications
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|
10
|
612
|
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
|
536
|
April 2, 2025
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