N-Nitroso Edoxaban Desmethyl Impurity CPCA Score
|
|
5
|
207
|
March 29, 2024
|
N-nitroso-rivaroxaban amide
|
|
1
|
186
|
March 28, 2024
|
Risk Assessment Study of Nitrosamines for the API Temozolomide Industrial Process -Pub
|
|
2
|
489
|
March 4, 2024
|
Antioxidant as a risk mitigation strategy
|
|
5
|
59
|
March 28, 2024
|
Request for risk assessment and confirmatory testing for nortriptyline containing products
|
|
2
|
79
|
March 27, 2024
|
π¨π¦ Health Canada updated the guidance and Appendix 1(March 15, 2024)
|
|
10
|
962
|
March 27, 2024
|
π© CPCA Calculation Tool (excel-based) -Updated
|
|
81
|
7156
|
March 27, 2024
|
Chemistry of N-Nitroso Ivacaftor
|
|
5
|
533
|
March 25, 2024
|
AI difference between FDA and EMA, HC and TGA
|
|
0
|
316
|
March 22, 2024
|
IVACAFTOR (N-Nitroso Ivacaftor)
|
|
0
|
124
|
March 22, 2024
|
Application of duplex sequencing to evaluate mutagenicity -Pub
|
|
1
|
127
|
March 14, 2024
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πΊπΈ FDA - Fiscal Year 2024 Generic Drug Science and Research Initatives Public Workshop
|
|
22
|
873
|
March 13, 2024
|
πͺπΊ OMCL Network published NDSRIs Analytical Methods
|
|
1
|
404
|
March 11, 2024
|
Simple and Practical Method for the Quantitative High-Sensitivity Analysis of N-Nitroso Duloxetine in Duloxetine Drug Products Utilizing LC-MS/MS
|
|
0
|
140
|
March 9, 2024
|
AI limit for N-Nitroso Losartan
|
|
4
|
210
|
March 9, 2024
|
Is it possible to observe N-nitrosamines formation from oximes? Do you have any reference to support the risk assessment for nitrosamine formation from the reaction of these functional groups in the presence of nitrosating agents? Thank you
|
|
2
|
190
|
February 27, 2024
|
πΊπΈ FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3
|
|
14
|
990
|
February 27, 2024
|
Nitrosamines: A new systematic review
|
|
7
|
1679
|
February 26, 2024
|
In Silico Prediction of Pharmaceutical Degradation Pathways: A Benchmarking Study Using the Software Program Zeneth
|
|
3
|
235
|
February 24, 2024
|
πΈπ¦ Saudi FDA requesting Nitrosamines Risk Assessments
|
|
1
|
767
|
February 22, 2024
|
Testig method for nitroso Ciprofloxacin
|
|
12
|
844
|
February 16, 2024
|
NDSRIs standards (for confirmatory testing or ames/other tests)
|
|
15
|
1138
|
February 14, 2024
|
Discussion on Cleaning Validation Requirements for Nitrosamines
|
|
2
|
284
|
February 14, 2024
|
Defining nitrosamine acceptable intake based on technical feasibible limit rather than CPCA
|
|
6
|
256
|
February 11, 2024
|
N- nitroso Nitazoxanide
|
|
1
|
214
|
February 8, 2024
|
Visualization of Categorized Compounds by CPCA
|
|
56
|
5533
|
February 5, 2024
|
Aromatic nitrogen "Is it possible for aromatic nitrogen to convert nitrosamine?"- Indole
|
|
10
|
1221
|
February 2, 2024
|
Swissmedic updated requirements for dealing with potential nitrosamine impurities in medicinal products
|
|
2
|
185
|
February 1, 2024
|
Nitrosamine Impurities in Topical Drug Product
|
|
3
|
387
|
February 3, 2024
|
Adoption of CPCA beyond FDA/ EMA
|
|
9
|
785
|
January 31, 2024
|