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About the Guidance, Documents, Resources category
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0
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623
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April 14, 2021
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Mutagenic Impurities in USP -future looking
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15
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1150
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April 30, 2026
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N-Nitroso dially amine estimation by LCMS
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2
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42
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April 29, 2026
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Regulatory Flexibilities and Clarifications: Chemistry, Manufacturing and Control (CMC) Information for Original First in Human (FIH) Phase 1 INDs
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0
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118
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April 23, 2026
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Analysis of Nitrite in Pharmaceutical Excipients: A Multi‑Laboratory Comparative Study - PUB
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1
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253
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April 7, 2026
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🇲🇽 Mexico Nitrosamine Guide published today
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46
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3549
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January 16, 2026
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Nitrosamine impurity evaluation in animal health API
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2
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107
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January 15, 2026
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Evaluation of Nitrosamine impurities in animal health APIs
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1
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134
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January 8, 2026
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Liquid medicinal product with lidocaine
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4
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184
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January 8, 2026
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Nitrosamine impurities in animal health APIs
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1
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173
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December 24, 2025
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Establishing Best Practice for N- Nitrosamine Read-Across and Surrogate Selection
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0
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160
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December 22, 2025
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🇪🇬 Egypt (EDA) Public Consultation regarding the Guidelines for Nitrosamine Impurities
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0
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113
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November 19, 2025
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EMA - nitrosamines Leading Member State (LMS)
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2
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325
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November 13, 2025
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N-nitrosamine occurrence in disinfected drinking water
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0
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253
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November 5, 2025
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🖥 Nitrosamines risk from Water for Pharmaceutical Purpose according to USP
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2
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952
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October 24, 2025
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IPEC Excipient new questionnaire, October 2025
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2
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254
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October 23, 2025
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Updated: IPEC Questionnaire for Excipient Nitrosamines Risk Evaluation
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2
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637
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October 23, 2025
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Understanding nitrosamine risk in listed medicines
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2
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382
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October 14, 2025
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EMA Q&A Rev. 22 (EMA/409815/2020 Rev.22)
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5
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2428
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October 10, 2025
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🇺🇸 US FDA- Generic Drug Science and Research Priority Initiatives for Fiscal Year (FY) 2026
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0
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257
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October 6, 2025
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🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2
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65
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6095
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October 3, 2025
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Quantitative genotoxicity assessment of N-nitrosodimethylamine in mice by error-corrected next-generation sequencing and DNA methylation quantification for toxicity threshold determination
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2
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158
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September 24, 2025
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Computational Mechanistic Study on N-Nitrosation Reaction of Secondary Amines
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0
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372
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August 25, 2025
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Nitrite testing in Excipients
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2
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563
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August 17, 2025
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:canada: Health Canada Extended Deadline
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5
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718
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August 3, 2025
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Nitrosamine impurities in human medicines/ European Medicines Regulatory Network
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0
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350
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July 29, 2025
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Nitrosamine Control Strategies: From Risk Identification to Implementation
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3
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437
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July 24, 2025
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N-nitrosamine risk assessment in pharmaceuticals: Where are we from a regulatory point of view in 2025?
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0
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391
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July 24, 2025
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Highlights from the 13th meeting of the Nitrosamine Implementation Oversight Group (NIOG)
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7
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516
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July 22, 2025
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Analytical Procedures and Validation_Specificity parameter requirment
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9
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637
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July 9, 2025
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