Case Studies for CPCA Scoring
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18
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4062
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September 30, 2024
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π© CPCA Calculation Tool (excel-based) -Updated
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87
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10809
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September 27, 2024
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Multiple Secondary Amine Groups in the Same Molecule
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2
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211
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September 26, 2024
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Royal Australian Chemical Institute
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0
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79
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September 26, 2024
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New paper - Use of molar, instead of weight-based, safety limits
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17
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2719
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September 25, 2024
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57th Congress of the European Societies of Toxicology (EUROTOX 2023)
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2
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686
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September 24, 2024
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Cleaning Validation Swab Sampling for Nitrosamine Impurities
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1
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177
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September 24, 2024
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Residual limits of nitrosamine impurities in cleaning validation
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0
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130
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September 24, 2024
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Low-concentration nitrosamine impurity sample detection method
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0
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106
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September 24, 2024
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Presencia de Nitrosaminas en Materiales de empaque. Presence of Nitrosamines in packaging materials
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4
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306
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September 23, 2024
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Facing Up to the New Nemesis of Pharma: Nitrosamines Whatβs going on with nitrosamines in pharmaceutical products? Naiffer Romero, Principal Scientist at the US Pharmacopeia walks us through frequently asked questions
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0
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183
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September 23, 2024
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Primeros pasos para evaluar nitrosaminas en medicamentos
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5
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179
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September 23, 2024
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πββοΈ Citizen Petition to FDA on Sitagliptin
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21
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3475
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June 7, 2024
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Dietary exposure assessment for volatile N-nitrosamines from food and beverages for the U.S. population -Pub
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0
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110
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September 18, 2024
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9th Impurities: Genotoxic, Nitrosamine, & Beyond Summit
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0
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336
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September 18, 2024
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Exposure to Valsartan Products Containing Nitrosamine Impurities in the United States, Canada, and Denmark
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0
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85
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September 18, 2024
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Escaping the cohort of concern: in vitro experimental evidence supports non-mutagenicity of N-nitroso-hydrochlorothiazide -Pub
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1
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208
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September 18, 2024
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PMDA-USP Workshop - Nitrosamines Track
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2
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493
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September 17, 2024
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Metformin drugs under simulated gastric conditions can generate high nitrite-dependent levels of N-nitrosodimethylamine
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5
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942
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September 17, 2024
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FDA-CDER and HESI | Nitrosamine Ames Data Review and Method Development Workshop
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1
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239
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September 17, 2024
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N-Nitroso Carbidopa
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2
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272
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September 12, 2024
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Can API with amide should considered a potential candidate for forming nitrosamine impurity
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5
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286
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September 12, 2024
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How to calculate limits for Di nitrosamine compounds in API, eg: 1,4-Di-ntrosopirrazine
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4
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224
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September 11, 2024
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Determining Low PPB Levels of Nitrite in Polymeric Excipients
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0
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195
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September 10, 2024
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Novartis pauses some trials of cancer drug Kisqali to fix manufacturing
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13
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1831
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September 9, 2024
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NDMA testing in metformin
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5
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205
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September 9, 2024
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Potential Topic for an event concerning obtaining the right level of Nitrosamine Risk Assessment information from your CMOs
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22
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1621
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September 5, 2024
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Vildaglibtin and Metformin in combinationy
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1
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529
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October 17, 2023
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EMA Q&A Appendix 1 is updated Sept 4, 2024
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18
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1586
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September 6, 2024
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Negative EAT could probably result in ICH Q3B?
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10
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337
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September 5, 2024
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