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3
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105
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October 3, 2023
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Variation requirements
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2
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84
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Visualization of Categorized Compounds by CPCA
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45
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2618
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关于2023药物杂质控制国际交流会的资讯
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1
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88
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Autonomous CPCA Web-based calculator FREE
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16
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443
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N-nitroso Torasemide Impurity formation and control
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14
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389
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🇺🇸 FDA - Recommended Acceptable Intake Limits for NDSRIs Guidance for Industry
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47
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2855
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September 20, 2023
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Nitrosamine in DS and DP specifications
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2
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285
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September 20, 2023
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Apixaban Drug Substance-Related Impurities (NDSRIs)
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3
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334
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🇪🇺 EMA Q&A Rev. 16 EMA/409815/2020 - MAJOR UPDATE
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108
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🖩 CPCA Calculation Tool (excel-based) -Updated
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68
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3236
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Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
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1
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333
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September 8, 2023
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DP Method transfer and verification
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8
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248
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August 31, 2023
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Optimized method development strategies for the quantification of small and complex N-nitrosamines impurities
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0
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194
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August 25, 2023
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Approaches and Considerations for the Investigation and Synthesis of N‑Nitrosamine Drug Substance-Related Impurities (NDSRIs)
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0
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210
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August 23, 2023
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Nitrosaminas: Estrutura química vs Potencial carcinogênico
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3
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245
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August 23, 2023
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N-Nitroso N-Desmethyl Nefopam
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4
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287
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August 18, 2023
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CPCA is now included in the updated version of Health Canada’s Guidance on nitrosamine impurities
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12
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669
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August 16, 2023
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Total impurities limit if more than one nitrosamine impurities are observed in product
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4
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259
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August 14, 2023
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Planilha CPCA na prática
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0
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150
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August 6, 2023
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Personal perspective on N-Nitrosamines and recent revision of guidelines
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6
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310
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July 28, 2023
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FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
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11
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1446
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Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
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3
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382
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July 26, 2023
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Case Studies for CPCA Scoring
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12
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1264
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July 25, 2023
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NDSRIs: Atualizações e Desafios
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0
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196
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July 24, 2023
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Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines
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3
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468
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July 21, 2023
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Forced degradation: predicting nitrosamine formation
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8
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711
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July 20, 2023
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🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments
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0
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365
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July 18, 2023
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😞 Aripiprazole is not approvable since 'major objections' have been identified
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6
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387
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July 18, 2023
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Strategies for Mitigating In-Source Fragmentation in NDSRI Analysis using LC-MS
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2
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477
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July 3, 2023
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