Can API with amide should considered a potential candidate for forming nitrosamine impurity
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5
|
344
|
September 12, 2024
|
Synthesis and mutagenic risk of avanafil's potential genotoxic impurities -Pub
|
|
0
|
104
|
August 25, 2024
|
AMES Test Study Designs for Nitrosamine Mutagenicity Testing -Pub
|
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10
|
1221
|
August 13, 2024
|
Gut Microbiotica Carcinogen Metabolism - Nitrosamines
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5
|
178
|
August 7, 2024
|
Strategy to Assess and Control Nitrosamine Formation in API during Storage: A Sitagliptin Case Study
|
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0
|
350
|
August 6, 2024
|
N-Nitroso Imidazole content in Clotrimazole
|
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4
|
290
|
August 5, 2024
|
N-nitroso Tamsulosin identification in Tamsulosin Products by LC-MS/MS
|
|
0
|
244
|
August 1, 2024
|
Risk Evaluation of N-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody–Drug Conjugates -Pub
|
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2
|
258
|
July 31, 2024
|
Valsartan, Losartan and Irbesartan use in the USA, UK, Canada and Denmark after the nitrosamine recalls: a descriptive cohort study -Pub
|
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1
|
233
|
July 31, 2024
|
Kinetic Model for Assessing Potential Nitrosamine Carcinogenicity
|
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1
|
139
|
July 30, 2024
|
Using the relative potency comparison approach, Powley et al have demonstrated the safety of NTTP exposures at or above levels of 1500 ng/day
|
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1
|
258
|
July 30, 2024
|
Nitrosamine Contamination of Pharmaceuticals: Cases in Japan, Formation Mechanisms, Detection Methods, Regulatory Perspectives, and Insights -Pub
|
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1
|
173
|
July 30, 2024
|
How to overcome the challenges of manual read-across when assessing nitrosamine acceptable intake limits
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0
|
127
|
July 26, 2024
|
Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies -Pub
|
|
0
|
545
|
July 23, 2024
|
Quantum Mechanical Assessment of Nitrosamine Potency -Pub
|
|
3
|
435
|
July 15, 2024
|
AZIDO Impurities Topic
|
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4
|
1282
|
July 11, 2024
|
A Case to Support the Continued Use of Rifampin in Clinical Drug–Drug Interaction Studies -Pub
|
|
0
|
167
|
July 10, 2024
|
Non-mutagenic, carcinogenic impurities
|
|
3
|
523
|
June 30, 2024
|
Discussion on Cleaning Validation Requirements for Nitrosamines
|
|
3
|
1030
|
June 24, 2024
|
On the role of digital tools in nitrosamine risk assessment for drug substance and drug product manufacturing processes -Pub
|
|
0
|
193
|
June 13, 2024
|
EMA-funded project to predict in-vivo mutagenicity / mutagenicity classification
|
|
9
|
1040
|
June 11, 2024
|
A new root cause? NOx
|
|
13
|
1874
|
November 17, 2023
|
Formaldehyde Catalysis of Nitrosamine Formation
|
|
3
|
633
|
May 31, 2024
|
⚙️🌎CPCA: the gestation, birth, and development -Pub
|
|
5
|
1165
|
May 31, 2024
|
Genotoxicity assessments of N-nitrosoethylisopropylamine (NEIPA) and N-nitrosodiisopropylamine (NDIPA) in the C57BL/6J mouse -Pub
|
|
0
|
297
|
May 13, 2024
|
Nitrosamines: A new systematic review
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|
8
|
3121
|
April 13, 2024
|
SOT posters and talks, (shared posters -update)
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|
3
|
841
|
April 10, 2024
|
1st release of Lhasa 'Complex Nitrosamines' data sharing initiative
|
|
6
|
1076
|
March 31, 2024
|
Antioxidant as a risk mitigation strategy
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|
5
|
753
|
March 28, 2024
|
Acceptable Intakes (AIs) for 11 Small molecule N-nitrosamines (NAs) -Pub
|
|
17
|
2745
|
March 28, 2024
|