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DMF in API, specification limit in formulation
|
|
5
|
906
|
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
|
165
|
August 25, 2024
|
|
NDSRI of Doxepin
|
|
6
|
868
|
August 14, 2024
|
|
Nitrosamine impurities of related substances of API's
|
|
7
|
1042
|
August 12, 2024
|
|
EMA Q&A Appendix 1 update posted on Feb. 26, 2024
|
|
29
|
4930
|
August 5, 2024
|
|
🇨🇦 Health Canada updated the guidance and Appendix 1(May 31, 2024)
|
|
18
|
3404
|
July 30, 2024
|
|
🇺🇸 FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3
|
|
16
|
4528
|
July 28, 2024
|
|
Nitrosamine Acceptable Intake Limits
|
|
2
|
819
|
July 10, 2024
|
|
Control limit of Nitrosamines and N-nitroso compounds
|
|
2
|
518
|
July 8, 2024
|
|
Nitroso lisinopril
|
|
3
|
544
|
July 4, 2024
|
|
Nitroso Dimethyl anthranilate
|
|
7
|
470
|
June 29, 2024
|
|
N-nitroso Solifenacin
|
|
7
|
464
|
June 28, 2024
|
|
Tetrazole nitrosamines
|
|
1
|
308
|
June 13, 2024
|
|
N-Nitroso Hydrochlorothiazide in Hydrochlorothiazide drug substance
|
|
12
|
4443
|
June 11, 2024
|
|
Limit for API having two NDSRI
|
|
14
|
2650
|
June 11, 2024
|
|
Lhasa TD50 or Gold TD50 to set AI limit?
|
|
8
|
892
|
June 10, 2024
|
|
CPCA Category 5 (AI 1500 ng/day) for NDIPA by Health Canada
|
|
2
|
510
|
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
|
521
|
June 9, 2024
|
|
Structuring expert review using AOPs: Enabling robust weight-of-evidence assessments for carcinogenicity under ICH S1B(R1)
|
|
0
|
303
|
June 9, 2024
|
|
Nitrosamines impurities and ICH M7
|
|
1
|
350
|
June 4, 2024
|
|
🇨🇦 Health Canada updated the guidance and Appendix 1(March 15, 2024)
|
|
11
|
3707
|
June 3, 2024
|
|
AI limit of API having very law MDD
|
|
1
|
376
|
May 27, 2024
|
|
N-nitrososarcosine limit
|
|
5
|
813
|
May 23, 2024
|
|
Acceptable intake (AI) of N-Nitroso-N-methylbenzylamine (CAS 937-40-6)
|
|
4
|
588
|
May 21, 2024
|
|
Category 5 NDSRIs- CPCA tool
|
|
2
|
567
|
May 20, 2024
|
|
Hot of the presses - New CPCA paper
|
|
1
|
448
|
May 17, 2024
|
|
Nitrosamine AI limit calculation if the risk is coming only out of excipients'
|
|
11
|
1397
|
May 13, 2024
|
|
N-Nitroso Metformin
|
|
8
|
2170
|
January 29, 2024
|
|
Nitrosamines Published Limits -reference
|
|
79
|
18114
|
May 10, 2024
|
|
NDSRI Limit of those product's having lower MDD
|
|
1
|
615
|
May 6, 2024
|