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About the Guidance, Documents, Resources category
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0
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647
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April 14, 2021
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The TGA updated information for acceptable intake of nitrosamine impurities in medicines on 14 August 2026
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0
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401
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August 14, 2026
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🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2
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63
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6937
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October 3, 2025
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N-Nitroso Abacavir Impurity possibility in physical state as standard
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5
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153
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August 1, 2026
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Requirements for NAs assessment in Russia
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8
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456
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July 10, 2026
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Indian Pharmacopoeia introduces a new General Chapter on Nitrosamine Impurities in its 2022 edition
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4
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2072
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June 26, 2026
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Mutagenic Impurities in USP -future looking
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17
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1680
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June 26, 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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2
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368
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June 25, 2026
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Upcoming EMA Q&A for other nitrosocompounds
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3
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481
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June 5, 2026
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An updated version of Health Canada's Guidance on nitrosamine impurities in medications(Update May 29, 2026)
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0
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334
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June 2, 2026
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Analysis of Nitrite in Pharmaceutical Excipients: A Multi‑Laboratory Comparative Study - PUB
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3
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494
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June 1, 2026
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🇰🇷 MFDS Guideline: Compilation of Analysis Methods on the Determination of Impurities in Pharmaceuticals, May-2026
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2
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331
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May 19, 2026
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N-Nitroso Mefanaminc Acid
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1
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157
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May 12, 2026
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N-Nitroso dially amine estimation by LCMS
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2
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99
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April 29, 2026
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🇲🇽 Mexico Nitrosamine Guide published today
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46
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4109
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January 16, 2026
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Nitrosamine impurity evaluation in animal health API
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1
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145
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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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161
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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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224
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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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228
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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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185
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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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127
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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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360
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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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259
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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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1078
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October 24, 2025
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IPEC Excipient new questionnaire, October 2025
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1
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301
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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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770
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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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483
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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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3135
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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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293
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October 6, 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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254
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September 24, 2025
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