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About the Limits of Nitrosamines category
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0
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1002
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April 14, 2021
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:australia: TGA - Latest Update to Nitrosamine Limits
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10
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2167
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November 3, 2025
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EMA - Appendix 1 - Update
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64
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5978
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October 30, 2025
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EMA has updated its AI limits on 01 Aug 2025
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17
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2025
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October 28, 2025
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N-Nitroso Sertraline
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9
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780
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October 23, 2025
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N-Nitroso mirabegron
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7
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2631
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October 15, 2025
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Help/Information needed: Are bis-Aryl-Azoxy-compounds CoC or not?
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3
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156
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October 13, 2025
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LTL Approach for New Generic Registrations
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5
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393
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October 10, 2025
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Nitrosamines without published AI, and possibly negative for carcinogenicity
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11
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1232
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October 7, 2025
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N-Nitroso-API calculation limit
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8
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516
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September 30, 2025
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Estimation of genotoxic nitroso amines impurities in empagliflozin
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2
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244
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September 15, 2025
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Alignment between Regulatory Agencies
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2
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372
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September 12, 2025
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Ask for help with limit for Nitroso-olaparib
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2
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161
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September 4, 2025
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N-nitroso-omadacycline mutagenic
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3
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113
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September 2, 2025
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Why EMA has done read-across for N-nitroso-desmethyl-doxylamine?
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9
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298
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September 1, 2025
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Why do nitrosamine impurities of omacycline and tigecycline have different AI values?
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8
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328
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August 28, 2025
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N-nitroso-Impurity C in Metamizol Drug product
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27
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2523
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August 22, 2025
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Published limit for N-Nitroso-Vonoprazan
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2
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263
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August 15, 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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4532
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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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567
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July 16, 2025
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MEGLUMINE (Methylglucamine)
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27
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3239
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July 10, 2025
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Criterios de aceptación
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2
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92
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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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504
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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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2834
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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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215
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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
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1230
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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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207
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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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208
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June 6, 2025
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AI limit for 1-Nitrosopiperazine
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8
|
440
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June 4, 2025
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Limits for NDMA in Dapagliflozin+Metformin
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19
|
500
|
May 28, 2025
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