How much Amine and Nitrating agent "Stoichiometric Ratio" required for formation of Nitrosamine impurities?
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3
|
176
|
August 28, 2024
|
Seventh European Medicines Agency - Medicines for Europe annual bilateral meeting
|
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1
|
98
|
August 27, 2024
|
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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0
|
104
|
August 25, 2024
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Suppressing Nitrosamine Drug Substance Related Impurities by Solid Dispersion
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1
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265
|
August 22, 2024
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π
FDA - CRCG Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products -Event
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1
|
915
|
August 14, 2024
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AI for NDSRI by Brazil regulatory
|
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6
|
793
|
August 7, 2024
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Strategy to Assess and Control Nitrosamine Formation in API during Storage: A Sitagliptin Case Study
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0
|
285
|
August 6, 2024
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π¨βπ» Dashboard Containing Published AI Limits
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32
|
3422
|
August 2, 2024
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The clinical and regulatory status of NDSRI: A global imperative -Pub
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1
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231
|
July 30, 2024
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π¨π¦ Health Canada updated the guidance and Appendix 1(May 31, 2024)
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18
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2275
|
July 30, 2024
|
Swissmedic updated requirements for dealing with potential nitrosamine impurities in medicinal products
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3
|
494
|
July 28, 2024
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πΊπΈ FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3
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16
|
3437
|
July 28, 2024
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Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
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8
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1325
|
July 27, 2024
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How to overcome the challenges of manual read-across when assessing nitrosamine acceptable intake limits
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0
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120
|
July 26, 2024
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Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines
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5
|
1163
|
July 20, 2024
|
Control limit of Nitrosamines and N-nitroso compounds
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2
|
399
|
July 8, 2024
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Discussion on Cleaning Validation Requirements for Nitrosamines
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3
|
903
|
June 24, 2024
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Tetrazole nitrosamines
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1
|
266
|
June 13, 2024
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Quelles Nitrosamines la Picloxidine est-elle susceptible de former?
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1
|
313
|
June 12, 2024
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Limit for API having two NDSRI
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14
|
2260
|
June 11, 2024
|
Examining the Use of Surrogates in Combination with The Carcinogenic Potency Categorization Approach when Establishing Acceptable Intake Limits of N-Nitrosamine Impurities
|
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0
|
451
|
June 9, 2024
|
Structuring expert review using AOPs: Enabling robust weight-of-evidence assessments for carcinogenicity under ICH S1B(R1)
|
|
0
|
275
|
June 9, 2024
|
Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
|
|
16
|
3295
|
June 8, 2024
|
Update: EFPIA workflows for Quality Risk management Jun 2024 v03
|
|
2
|
627
|
June 4, 2024
|
π¨π¦ Health Canada updated the guidance and Appendix 1(March 15, 2024)
|
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11
|
3000
|
June 3, 2024
|
Visualization of Categorized Compounds by CPCA
|
|
64
|
8022
|
June 1, 2024
|
πΊπΈ FDA - Fiscal Year 2024 Generic Drug Science and Research Initatives Public Workshop
|
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33
|
1903
|
September 5, 2024
|
N-nitroso-nitrofurantoin
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0
|
251
|
May 31, 2024
|
βοΈπCPCA: the gestation, birth, and development -Pub
|
|
5
|
1134
|
May 31, 2024
|
Category 5 NDSRIs- CPCA tool
|
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2
|
455
|
May 20, 2024
|