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About the Guidance, Documents, Resources category
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0
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529
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April 14, 2021
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ICH M7 & Nitrosamines Impurities -Updates
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15
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3084
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January 20, 2025
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Control Strategy - Testing Frequency
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10
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319
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January 20, 2025
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🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2
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46
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3107
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January 18, 2025
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🇲🇽 Mexico Q&A Live session streaming
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7
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472
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January 6, 2025
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Critical comparison of BMD and TD50 methods for the calculation of acceptable intakes for N-nitroso compounds -Pub
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0
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236
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January 3, 2025
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CHPA's response to the Control of Nitrosamine Impurities in Human Drugs rev.2
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1
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344
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January 2, 2025
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AI for pharmaceutical legislation, including nitrosamines
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4
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323
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December 30, 2024
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WHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products
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4
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1095
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December 21, 2024
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EMA nitrosamine Q&A Appendix 1 rev.7 published on Dec 13, 2024
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6
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976
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December 16, 2024
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Autonomous CPCA Web-based calculator FREE
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31
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5380
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December 12, 2024
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Nitrosamine Mitigation: A Path to Regulatory Compliance
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0
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287
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November 22, 2024
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🇲🇽 Mexico Nitrosamine Guide published today
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42
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2591
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November 22, 2024
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Methylene Blue NDSRI
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6
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462
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November 22, 2024
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New EMA Nitrosamine impurities page
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0
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379
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November 21, 2024
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Terbinafine Nitrosamines
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3
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166
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November 14, 2024
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NDSRI limit for N-nitroso Ciprofloxacin
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2
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234
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November 1, 2024
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FDA Statement on Ritonavir and NITMA
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1
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223
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October 29, 2024
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Hexamethyldisilazane (HMDS) can form Nitrosamine Impurity?
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7
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504
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October 29, 2024
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N-Nitrosamine drug substance related impurities (NDSRIs) – A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da -Pub
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0
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216
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October 28, 2024
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Nitroso Betahistine Impurity C
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2
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120
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October 28, 2024
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Use of L-cysteine as nitrite scavenging
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6
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230
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October 25, 2024
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Selection of Solvent and Positive Control Concentration for Enhanced AMES Test -Pub
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0
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100
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October 14, 2024
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Oral Liquid Formulations
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4
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176
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October 14, 2024
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🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments
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5
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1654
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October 9, 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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NDMA testing in metformin
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5
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206
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September 9, 2024
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Vildaglibtin and Metformin in combinationy
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1
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531
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October 17, 2023
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USP - CPCA Nitrosamines Case Study
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7
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1457
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August 30, 2024
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Resources to help educate reluctant excipient suppliers?
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7
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330
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August 28, 2024
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