|
Australia TGA - postpone until end of Jun 2024 NTTP 37ng/day
|
|
0
|
529
|
December 15, 2023
|
|
Updated FDA list of published limits
|
|
15
|
4852
|
December 15, 2023
|
|
Nitrosamine due to preservative in ophthalmic
|
|
3
|
901
|
December 8, 2023
|
|
Control of NDSRIs impurity at Drug Substance (API) specification
|
|
8
|
1469
|
December 5, 2023
|
|
Differences of limit of EMA and FDA regulatory for category 1
|
|
0
|
580
|
November 23, 2023
|
|
CPCA Calculation System (Python Desktop)
|
|
1
|
1608
|
November 22, 2023
|
|
Use of the TD50 99 % CI for single dose rodent carcinogenicity studies -Pub
|
|
5
|
669
|
November 16, 2023
|
|
AI for NDSRIs with positive EAT and/or in-vivo mutagenicity study - FDA position?
|
|
2
|
708
|
November 9, 2023
|
|
N-Nitroso desmethyl bedaquiline
|
|
0
|
697
|
October 6, 2023
|
|
Nitrosamine in DS and DP specifications
|
|
2
|
877
|
September 20, 2023
|
|
N-nitroso-duloxetine
|
|
1
|
629
|
September 19, 2023
|
|
Omission of specification <10% AI
|
|
2
|
1122
|
September 12, 2023
|
|
Read-across/SAR posts Collection
|
|
10
|
3113
|
September 7, 2023
|
|
Kinetic model to estimate the amount of nitrosamines
|
|
5
|
919
|
September 6, 2023
|
|
Higher limits allowed by FDA for Nitroso-sitagliptin
|
|
20
|
5118
|
August 28, 2023
|
|
Nitroso-methylphenidate
|
|
4
|
794
|
August 25, 2023
|
|
CPCA - Methyl group bonded to beta carbon (cyclic/acyclic) (activating factor)
|
|
2
|
1578
|
August 23, 2023
|
|
N-Nitroso N-Desmethyl Nefopam
|
|
4
|
1020
|
August 18, 2023
|
|
Total impurities limit if more than one nitrosamine impurities are observed in product
|
|
4
|
721
|
August 14, 2023
|
|
N-nitroso-hydrochlorothiazide limit
|
|
2
|
661
|
August 14, 2023
|
|
Testing of APIs for NDSRI
|
|
4
|
1158
|
August 10, 2023
|
|
Common nitrosamine impurity limit calculation when it is contributing from both API as well as excipients
|
|
9
|
1366
|
August 8, 2023
|
|
NDMA in Drug Product
|
|
2
|
550
|
August 3, 2023
|
|
Use of the less-than lifetime (LTL) concept or the use of interim limits
|
|
3
|
1129
|
August 1, 2023
|
|
LTL in simple terms?
|
|
7
|
799
|
July 1, 2022
|
|
N-nitroso desloratadine?
|
|
13
|
1959
|
July 22, 2023
|
|
How important clinically are nitrosamines?
|
|
5
|
506
|
July 19, 2023
|
|
Proposed approach to Temporary Acceptable intake Limits for NDSRIs
|
|
10
|
1407
|
July 6, 2023
|
|
Limits of nitrosamine impurity below 10 ppm in drug products
|
|
0
|
708
|
June 19, 2023
|
|
Limits for N-nitroso vortioxetine
|
|
3
|
1528
|
June 15, 2023
|