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Quantification of 13 N-Nitrosamines in Pharmaceuticals using SPE-LC-MS/MS
|
|
0
|
1120
|
December 13, 2023
|
|
MDD for API/DP for Ophthalmic Formulation
|
|
4
|
1184
|
December 12, 2023
|
|
10º encontro Farmacopeia Brasileira
|
|
0
|
532
|
November 30, 2023
|
|
Does atmospheric NO2 influence the formation of NDMA in metformin?
|
|
2
|
642
|
November 3, 2023
|
|
Vilazodone Nitrosamine
|
|
0
|
471
|
October 31, 2023
|
|
Lumateperone tosylate NDSRI impurity
|
|
1
|
926
|
October 6, 2023
|
|
Variation requirements
|
|
2
|
469
|
October 2, 2023
|
|
🇺🇸 FDA - Recommended Acceptable Intake Limits for NDSRIs Guidance for Industry
|
|
47
|
7614
|
September 20, 2023
|
|
Nitrosamine in DS and DP specifications
|
|
2
|
874
|
September 20, 2023
|
|
Apixaban Drug Substance-Related Impurities (NDSRIs)
|
|
3
|
1697
|
September 15, 2023
|
|
Nitrite Detection at Picogram Level, is it possible?
|
|
4
|
1167
|
September 14, 2023
|
|
🇪🇺 EMA Q&A Rev. 16 EMA/409815/2020 - MAJOR UPDATE
|
|
108
|
25904
|
September 12, 2023
|
|
Strategies for Assessing Acceptable Intakes for Novel N-Nitrosamines Derived from Active Pharmaceutical Ingredients
|
|
4
|
695
|
August 23, 2023
|
|
Nitrosaminas: Estrutura química vs Potencial carcinogênico
|
|
3
|
597
|
August 23, 2023
|
|
Total impurities limit if more than one nitrosamine impurities are observed in product
|
|
4
|
718
|
August 14, 2023
|
|
Planilha CPCA na prática
|
|
0
|
500
|
August 6, 2023
|
|
The Nitrosamine “Saga”
|
|
3
|
1652
|
July 29, 2023
|
|
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
|
|
11
|
3992
|
July 27, 2023
|
|
NDSRIs: Atualizações e Desafios
|
|
0
|
496
|
July 24, 2023
|
|
Forced degradation: predicting nitrosamine formation
|
|
8
|
2100
|
July 20, 2023
|
|
Establishment of Acceptable Intakes, framework
|
|
12
|
887
|
July 12, 2023
|
|
Strategies for Mitigating In-Source Fragmentation in NDSRI Analysis using LC-MS
|
|
2
|
2628
|
July 3, 2023
|
|
Losartan azide impurity confirmed as not an in vivo mutagen compound
|
|
5
|
1784
|
June 20, 2023
|
|
Guideline ANVISA - Brazil: version 3, updates
|
|
8
|
3614
|
June 19, 2023
|
|
The 18 ng/day default for NDSRIs should be re-visited?
|
|
8
|
964
|
June 14, 2023
|
|
Formation of N-nitroso Fluconazole and Related Triazole-Imidazole APIs
|
|
4
|
1484
|
June 9, 2023
|
|
Evidence on the Carcinogenicity of Nitrite in Combination with Amines or Amides
|
|
0
|
548
|
June 6, 2023
|
|
FDA/HESI Collaborative Roadmap: Advancing Hazard and Risk Assessment of Nitrosamine Impurities in Pharmaceuticals
|
|
2
|
952
|
June 5, 2023
|
|
Fda行业指南中总亚硝胺杂质含量要求
|
|
1
|
719
|
June 2, 2023
|
|
N-nitroso Des-methyl Dapoxetine
|
|
12
|
1320
|
May 31, 2023
|