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USP - CPCA Nitrosamines Case Study
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7
|
1604
|
August 30, 2024
|
|
4-(nitroso(vinyl)amino)butanoic acid from Kollidon?
|
|
7
|
506
|
August 29, 2024
|
|
FDA NDSRI limits not aligned with HC/EMA
|
|
0
|
444
|
August 29, 2024
|
|
Anybody inquired about Nitrosamines in Poly bags?
|
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8
|
1707
|
August 29, 2024
|
|
Resources to help educate reluctant excipient suppliers?
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7
|
373
|
August 28, 2024
|
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How much Amine and Nitrating agent "Stoichiometric Ratio" required for formation of Nitrosamine impurities?
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3
|
329
|
August 28, 2024
|
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Seventh European Medicines Agency - Medicines for Europe annual bilateral meeting
|
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1
|
124
|
August 27, 2024
|
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Analytical methodologies to detect N-nitrosamine impurities in active pharmaceutical ingredients, drug products and other matrices -Pub
|
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0
|
483
|
August 27, 2024
|
|
DMF in API, specification limit in formulation
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5
|
871
|
August 26, 2024
|
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Synthesis and mutagenic risk of avanafil's potential genotoxic impurities -Pub
|
|
0
|
155
|
August 25, 2024
|
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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
|
|
0
|
152
|
August 25, 2024
|
|
N-Nitroso Ruxolitinib
|
|
10
|
1398
|
August 23, 2024
|
|
Suppressing Nitrosamine Drug Substance Related Impurities by Solid Dispersion
|
|
1
|
311
|
August 22, 2024
|
|
Regulatory Highlights(OPR&D)
|
|
15
|
2237
|
August 21, 2024
|
|
🇧🇷 Guideline for the control of Nitrosamines Rev. 4
|
|
24
|
2174
|
August 21, 2024
|
|
Sitagliptin NTTP nitrosamine impurity maximum active intake level 37ng to 246.7 ng/per day
|
|
29
|
6750
|
August 19, 2024
|
|
NDSRI of Doxepin
|
|
6
|
839
|
August 14, 2024
|
|
📅 FDA - CRCG Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products -Event
|
|
1
|
1022
|
August 14, 2024
|
|
Nitrosamine impurities of related substances of API's
|
|
7
|
973
|
August 12, 2024
|
|
Gut Microbiotica Carcinogen Metabolism - Nitrosamines
|
|
5
|
204
|
August 7, 2024
|
|
AI for NDSRI by Brazil regulatory
|
|
6
|
980
|
August 7, 2024
|
|
Strategy to Assess and Control Nitrosamine Formation in API during Storage: A Sitagliptin Case Study
|
|
0
|
452
|
August 6, 2024
|
|
EMA Q&A Appendix 1 update posted on Feb. 26, 2024
|
|
29
|
4718
|
August 5, 2024
|
|
South African Health Products Regulatory Authority (Nitrosamines)
|
|
2
|
761
|
August 5, 2024
|
|
N-nitroso Omeprazole
|
|
4
|
1807
|
August 3, 2024
|
|
N-nitroso Tamsulosin identification in Tamsulosin Products by LC-MS/MS
|
|
0
|
308
|
August 1, 2024
|
|
👨💻 Dashboard Containing Published AI Limits
|
|
32
|
3959
|
August 2, 2024
|
|
🇲🇽 Coming July Mexico Nitrosamines Guideline
|
|
5
|
516
|
August 2, 2024
|
|
Risk Evaluation of N-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody–Drug Conjugates -Pub
|
|
2
|
337
|
July 31, 2024
|
|
Valsartan, Losartan and Irbesartan use in the USA, UK, Canada and Denmark after the nitrosamine recalls: a descriptive cohort study -Pub
|
|
1
|
338
|
July 31, 2024
|