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Strategies for Assessing Acceptable Intakes for Novel N-Nitrosamines Derived from Active Pharmaceutical Ingredients
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4
|
578
|
August 23, 2023
|
|
Nitrosaminas: Estrutura química vs Potencial carcinogênico
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3
|
447
|
August 23, 2023
|
|
Total impurities limit if more than one nitrosamine impurities are observed in product
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4
|
507
|
August 14, 2023
|
|
Planilha CPCA na prática
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0
|
303
|
August 6, 2023
|
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The Nitrosamine “Saga”
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|
3
|
1413
|
July 29, 2023
|
|
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
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|
11
|
2662
|
July 27, 2023
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NDSRIs: Atualizações e Desafios
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0
|
361
|
July 24, 2023
|
|
Forced degradation: predicting nitrosamine formation
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8
|
1190
|
July 20, 2023
|
|
N-nitroso Omeprazole
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3
|
764
|
July 18, 2023
|
|
Establishment of Acceptable Intakes, framework
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|
12
|
565
|
July 12, 2023
|
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Strategies for Mitigating In-Source Fragmentation in NDSRI Analysis using LC-MS
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2
|
1172
|
July 3, 2023
|
|
Losartan azide impurity confirmed as not an in vivo mutagen compound
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5
|
1203
|
June 20, 2023
|
|
Guideline ANVISA - Brazil: version 3, updates
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|
8
|
2579
|
June 19, 2023
|
|
The 18 ng/day default for NDSRIs should be re-visited?
|
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8
|
809
|
June 14, 2023
|
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Formation of N-nitroso Fluconazole and Related Triazole-Imidazole APIs
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|
4
|
801
|
June 9, 2023
|
|
Evidence on the Carcinogenicity of Nitrite in Combination with Amines or Amides
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|
0
|
394
|
June 6, 2023
|
|
FDA/HESI Collaborative Roadmap: Advancing Hazard and Risk Assessment of Nitrosamine Impurities in Pharmaceuticals
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|
2
|
662
|
June 5, 2023
|
|
Fda行业指南中总亚硝胺杂质含量要求
|
|
1
|
464
|
June 2, 2023
|
|
N-nitroso Des-methyl Dapoxetine
|
|
12
|
917
|
May 31, 2023
|
|
Nitrosamine in Peptides
|
|
2
|
587
|
May 26, 2023
|
|
The acceptance Intake of Nitroso-Propranolol
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|
16
|
2904
|
May 24, 2023
|
|
Setting limit for Nitrite and Nitrate in water used for Active Ingredients synthesis
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|
2
|
906
|
May 23, 2023
|
|
Nuevas inspecciones en busca de Nitrosaminas y Genotóxicos en API no evaluados
|
|
1
|
510
|
May 1, 2023
|
|
NDMA formation Due to Active Ingredient Degradation and Nitrite Traces in Drug Product
|
|
0
|
642
|
March 24, 2023
|
|
确定DNSRI的限度需要同时进行Ames和致癌性实验吗？
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|
4
|
499
|
March 2, 2023
|
|
EMA Nitrosamine Q&A Rev14 published
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|
6
|
1159
|
February 23, 2023
|
|
Anybody has working with a Gliclazide nitrosamine?
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|
3
|
875
|
February 14, 2023
|
|
Carry over limits for Niitrsoamines
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|
2
|
571
|
February 12, 2023
|
|
Prediction of Nitrosamine formation from Excipients
|
|
19
|
1269
|
February 8, 2023
|
|
Nitroso-Diclofenac mutagenicity
|
|
13
|
1167
|
December 21, 2022
|