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About the Guidance, Documents, Resources category
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0
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573
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April 14, 2021
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🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2
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61
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4832
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June 14, 2025
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Addendum to ICH M7 on Risk Assessment and Control of N-Nitrosamine Impurities
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7
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963
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May 30, 2025
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Cleaning procedure for glassware used in the analysis of nitrosamines for LC-MS/MS
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2
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306
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May 23, 2025
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EMA Q&A Rev. 22 (EMA/409815/2020 Rev.22)
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4
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534
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May 20, 2025
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Nitrosamine Mitigation: A Path to Regulatory Compliance
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1
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420
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May 11, 2025
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Nitrosourea, aromatic n-nitroso copmounds
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2
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198
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May 2, 2025
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Autonomous CPCA Web-based calculator FREE
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33
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6011
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April 30, 2025
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Annex 2 WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products
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0
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362
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April 16, 2025
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Nitrosamines Safety Operational Expert Group
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0
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123
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April 16, 2025
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Clobam Nitrosamine Impurity
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0
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107
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April 8, 2025
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Acceptance criteria for Nitrosamines Method Validation
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3
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364
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March 14, 2025
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CDER Drug Safety Priorities Fiscal Year 2023
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2
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648
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February 27, 2025
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Adjustment of the MDD with CYP inducers?
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2
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149
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February 13, 2025
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EMA nitrosamine Q&A Appendix 1 rev.7 published on Dec 13, 2024
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8
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1870
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January 27, 2025
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ICH M7 & Nitrosamines Impurities -Updates
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15
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3975
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January 20, 2025
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Control Strategy - Testing Frequency
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10
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404
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January 20, 2025
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🇲🇽 Mexico Q&A Live session streaming
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7
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680
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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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269
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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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385
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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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363
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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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1151
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December 21, 2024
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🇲🇽 Mexico Nitrosamine Guide published today
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42
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2847
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November 22, 2024
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Methylene Blue NDSRI
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6
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536
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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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425
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November 21, 2024
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Terbinafine Nitrosamines
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3
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207
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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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290
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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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327
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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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539
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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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279
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October 28, 2024
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