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About the Limits of Nitrosamines category
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|
0
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350
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April 14, 2021
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Nitrosamine in DS and DP specifications
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|
2
|
248
|
September 20, 2023
|
|
Visualization of Categorized Compounds by CPCA
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|
44
|
2456
|
September 19, 2023
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|
N-nitroso-duloxetine
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|
1
|
111
|
September 19, 2023
|
|
Nitrosamines without published AI, and possibly negative for carcinogenicity
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|
9
|
510
|
September 18, 2023
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Omission of specification <10% AI
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|
2
|
271
|
September 12, 2023
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|
🖩 CPCA Calculation Tool (excel-based) -Updated
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68
|
3154
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September 11, 2023
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Read-across/SAR posts Collection
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|
10
|
1382
|
September 7, 2023
|
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Kinetic model to estimate the amount of nitrosamines
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|
5
|
292
|
September 6, 2023
|
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Higher limits allowed by FDA for Nitroso-sitagliptin
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|
20
|
2031
|
August 28, 2023
|
|
Nitroso-methylphenidate
|
|
4
|
171
|
August 25, 2023
|
|
CPCA - Methyl group bonded to beta carbon (cyclic/acyclic) (activating factor)
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|
2
|
411
|
August 23, 2023
|
|
MEGLUMINE (Methylglucamine)
|
|
11
|
698
|
August 23, 2023
|
|
N-Nitroso N-Desmethyl Nefopam
|
|
4
|
278
|
August 18, 2023
|
|
Total impurities limit if more than one nitrosamine impurities are observed in product
|
|
4
|
255
|
August 14, 2023
|
|
N-nitroso-hydrochlorothiazide limit
|
|
2
|
178
|
August 14, 2023
|
|
Testing of APIs for NDSRI
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|
4
|
434
|
August 10, 2023
|
|
Common nitrosamine impurity limit calculation when it is contributing from both API as well as excipients
|
|
9
|
804
|
August 8, 2023
|
|
AI for en Indole struktur (N-Nitroso melatonin)
|
|
4
|
227
|
August 4, 2023
|
|
NDMA in Drug Product
|
|
2
|
244
|
August 3, 2023
|
|
N-Nitroso mirabegron
|
|
4
|
1060
|
August 2, 2023
|
|
Use of the less-than lifetime (LTL) concept or the use of interim limits
|
|
3
|
321
|
August 1, 2023
|
|
LTL in simple terms?
|
|
7
|
433
|
July 1, 2022
|
|
Case Studies for CPCA Scoring
|
|
12
|
1206
|
July 25, 2023
|
|
N-nitroso desloratadine?
|
|
13
|
936
|
July 22, 2023
|
|
How important clinically are nitrosamines?
|
|
5
|
282
|
July 19, 2023
|
|
N-nitroso-Impurity C in Metamizol Drug product
|
|
4
|
270
|
July 10, 2023
|
|
N-Nitroso Hydrochlorothiazide in Hydrochlorothiazide drug substance
|
|
11
|
2183
|
July 8, 2023
|
|
Proposed approach to Temporary Acceptable intake Limits for NDSRIs
|
|
10
|
933
|
July 6, 2023
|
|
Nitrosamines Published Limits -reference
|
|
77
|
6492
|
July 5, 2023
|