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Variation requirements
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2
|
82
|
October 2, 2023
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Autonomous CPCA Web-based calculator FREE
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16
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443
|
September 27, 2023
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N-nitroso Torasemide Impurity formation and control
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14
|
388
|
September 26, 2023
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🇺🇸 FDA - Recommended Acceptable Intake Limits for NDSRIs Guidance for Industry
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47
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2854
|
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
|
333
|
September 15, 2023
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Nitrite Detection at Picogram Level, is it possible?
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4
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373
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September 14, 2023
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🇪🇺 EMA Q&A Rev. 16 EMA/409815/2020 - MAJOR UPDATE
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108
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6837
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September 12, 2023
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Formation of Nitroso-Omeprazole
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3
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558
|
September 8, 2023
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N-nitrosoamides - a horse of a different color
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32
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1512
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September 1, 2023
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Strategies for Assessing Acceptable Intakes for Novel N-Nitrosamines Derived from Active Pharmaceutical Ingredients
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4
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409
|
August 23, 2023
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MEGLUMINE (Methylglucamine)
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11
|
714
|
August 23, 2023
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Nitrosaminas: Estrutura química vs Potencial carcinogênico
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3
|
245
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August 23, 2023
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Total impurities limit if more than one nitrosamine impurities are observed in product
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4
|
259
|
August 14, 2023
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Planilha CPCA na prática
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0
|
150
|
August 6, 2023
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N-Nitrosamine impurity of heterocyclic aromatic ring
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8
|
1034
|
August 3, 2023
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The Nitrosamine “Saga”
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3
|
641
|
July 29, 2023
|
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FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
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11
|
1446
|
July 27, 2023
|
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NDSRIs: Atualizações e Desafios
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|
0
|
196
|
July 24, 2023
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|
Forced degradation: predicting nitrosamine formation
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|
8
|
711
|
July 20, 2023
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|
N-nitroso Omeprazole
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|
3
|
306
|
July 18, 2023
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|
Establishment of Acceptable Intakes, framework
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12
|
364
|
July 12, 2023
|
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Strategies for Mitigating In-Source Fragmentation in NDSRI Analysis using LC-MS
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2
|
476
|
July 3, 2023
|
|
Losartan azide impurity confirmed as not an in vivo mutagen compound
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5
|
737
|
June 20, 2023
|
|
Guideline ANVISA - Brazil: version 3, updates
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8
|
1299
|
June 19, 2023
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The 18 ng/day default for NDSRIs should be re-visited?
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|
8
|
585
|
June 14, 2023
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Formation of N-nitroso Fluconazole and Related Triazole-Imidazole APIs
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|
4
|
335
|
June 9, 2023
|
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Evidence on the Carcinogenicity of Nitrite in Combination with Amines or Amides
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|
0
|
193
|
June 6, 2023
|
|
FDA/HESI Collaborative Roadmap: Advancing Hazard and Risk Assessment of Nitrosamine Impurities in Pharmaceuticals
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|
2
|
420
|
June 5, 2023
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Fda行业指南中总亚硝胺杂质含量要求
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|
1
|
254
|
June 2, 2023
|