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Evaluation of the nitrosamine impurities of ACE inhibitors using computational, in vitro, and in vivo methods demonstrate no genotoxic potential -Pub
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7
|
394
|
September 3, 2024
|
|
FDA NDSRI limits not aligned with HC/EMA
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0
|
391
|
August 29, 2024
|
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Define MDD to calculate limit
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45
|
17412
|
August 27, 2024
|
|
DMF in API, specification limit in formulation
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5
|
700
|
August 26, 2024
|
|
Evaluation of the nitrosamine impurities of ACE inhibitors using computational, in vitro, and in vivo methods demonstrate no genotoxic potential-Pub
|
|
0
|
109
|
August 25, 2024
|
|
NDSRI of Doxepin
|
|
6
|
553
|
August 14, 2024
|
|
Nitrosamine impurities of related substances of API's
|
|
7
|
784
|
August 12, 2024
|
|
EMA Q&A Appendix 1 update posted on Feb. 26, 2024
|
|
29
|
3749
|
August 5, 2024
|
|
:australia: TGA - Latest Update to Nitrosamine Limits
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|
5
|
1311
|
July 30, 2024
|
|
🇨🇦 Health Canada updated the guidance and Appendix 1(May 31, 2024)
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|
18
|
2367
|
July 30, 2024
|
|
🇺🇸 FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3
|
|
16
|
3565
|
July 28, 2024
|
|
EMA - Appendix 1 - Update
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|
12
|
2174
|
July 10, 2024
|
|
Nitrosamine Acceptable Intake Limits
|
|
2
|
491
|
July 10, 2024
|
|
Control limit of Nitrosamines and N-nitroso compounds
|
|
2
|
408
|
July 8, 2024
|
|
Nitroso lisinopril
|
|
3
|
371
|
July 4, 2024
|
|
Nitroso Dimethyl anthranilate
|
|
7
|
372
|
June 29, 2024
|
|
N-nitroso Solifenacin
|
|
7
|
309
|
June 28, 2024
|
|
MEGLUMINE (Methylglucamine)
|
|
18
|
2518
|
June 19, 2024
|
|
Tetrazole nitrosamines
|
|
1
|
272
|
June 13, 2024
|
|
N-Nitroso Hydrochlorothiazide in Hydrochlorothiazide drug substance
|
|
12
|
4044
|
June 11, 2024
|
|
Limit for API having two NDSRI
|
|
14
|
2288
|
June 11, 2024
|
|
Lhasa TD50 or Gold TD50 to set AI limit?
|
|
8
|
668
|
June 10, 2024
|
|
CPCA Category 5 (AI 1500 ng/day) for NDIPA by Health Canada
|
|
2
|
449
|
June 6, 2024
|
|
Examining the Use of Surrogates in Combination with The Carcinogenic Potency Categorization Approach when Establishing Acceptable Intake Limits of N-Nitrosamine Impurities
|
|
0
|
457
|
June 9, 2024
|
|
Structuring expert review using AOPs: Enabling robust weight-of-evidence assessments for carcinogenicity under ICH S1B(R1)
|
|
0
|
277
|
June 9, 2024
|
|
Nitrosamines impurities and ICH M7
|
|
1
|
254
|
June 4, 2024
|
|
🇨🇦 Health Canada updated the guidance and Appendix 1(March 15, 2024)
|
|
11
|
3053
|
June 3, 2024
|
|
Visualization of Categorized Compounds by CPCA
|
|
64
|
8076
|
June 1, 2024
|
|
AI limit of API having very law MDD
|
|
1
|
322
|
May 27, 2024
|
|
N-nitrososarcosine limit
|
|
5
|
592
|
May 23, 2024
|