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Nitrosamines risk assessments for Topical herbal extracts
|
|
1
|
120
|
September 20, 2023
|
|
Apixaban Drug Substance-Related Impurities (NDSRIs)
|
|
3
|
315
|
September 15, 2023
|
|
MEGLUMINE (Methylglucamine)
|
|
11
|
698
|
August 23, 2023
|
|
Total impurities limit if more than one nitrosamine impurities are observed in product
|
|
4
|
255
|
August 14, 2023
|
|
The Nitrosamine “Saga”
|
|
3
|
624
|
July 29, 2023
|
|
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
|
|
11
|
1422
|
July 27, 2023
|
|
NDSRIs: Atualizações e Desafios
|
|
0
|
189
|
July 24, 2023
|
|
N-nitroso Des-methyl Dapoxetine
|
|
12
|
506
|
May 31, 2023
|
|
Setting limit for Nitrite and Nitrate in water used for Active Ingredients synthesis
|
|
2
|
389
|
May 23, 2023
|
|
Carry over limits for Niitrsoamines
|
|
2
|
352
|
February 12, 2023
|
|
Nitrosamine risks that may arise from the filters
|
|
2
|
323
|
January 4, 2023
|
|
Cleaning Validations Criteria
|
|
1
|
590
|
December 5, 2022
|
|
2 days seminar on nitrosamine and extractable & leachable
|
|
0
|
265
|
November 21, 2022
|
|
Nitrite / Nitrosamine levels in Excipients
|
|
0
|
274
|
November 17, 2022
|
|
AI Limit for Nitroso Nebivolol
|
|
8
|
1104
|
October 6, 2022
|
|
Azithromycin - presence of N-Nitrosamines
|
|
8
|
499
|
March 3, 2022
|
|
Mutagenic Impurities Strategies for Identification and Control - now published
|
|
9
|
275
|
March 2, 2022
|