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FDA updated information on recommended AI Sept 4, 2024
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1
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485
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September 4, 2024
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QSAR Toolbox - Free software. Any experience?
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18
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1713
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September 4, 2024
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Evaluation of the nitrosamine impurities of ACE inhibitors using computational, in vitro, and in vivo methods demonstrate no genotoxic potential -Pub
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7
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411
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September 3, 2024
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Pfizer Japan Seeks Partial Change of Champix’s Approval towards Re-Supply
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0
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143
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September 2, 2024
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N-Nitroso Metformin Chemistry
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2
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278
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September 2, 2024
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N-Nitroso Tizanidine
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1
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237
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August 31, 2024
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USP - CPCA Nitrosamines Case Study
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7
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1454
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August 30, 2024
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4-(nitroso(vinyl)amino)butanoic acid from Kollidon?
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7
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296
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August 29, 2024
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FDA NDSRI limits not aligned with HC/EMA
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0
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395
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August 29, 2024
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N-nitroso-rivaroxaban amide
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6
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1417
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August 29, 2024
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Anybody inquired about Nitrosamines in Poly bags?
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8
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1521
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August 29, 2024
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Resources to help educate reluctant excipient suppliers?
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7
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328
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August 28, 2024
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ICH M7 & Nitrosamines Impurities -Updates
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11
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2817
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August 28, 2024
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How much Amine and Nitrating agent "Stoichiometric Ratio" required for formation of Nitrosamine impurities?
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3
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194
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August 28, 2024
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Define MDD to calculate limit
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45
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17884
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August 27, 2024
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Seventh European Medicines Agency - Medicines for Europe annual bilateral meeting
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1
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101
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August 27, 2024
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Analytical methodologies to detect N-nitrosamine impurities in active pharmaceutical ingredients, drug products and other matrices -Pub
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0
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246
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August 27, 2024
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Health Canada: Nitrosamine impurities Update July 26, 2024
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14
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1108
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August 26, 2024
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DMF in API, specification limit in formulation
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5
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718
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August 26, 2024
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Synthesis and mutagenic risk of avanafil's potential genotoxic impurities -Pub
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0
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93
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August 25, 2024
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Evaluation of the nitrosamine impurities of ACE inhibitors using computational, in vitro, and in vivo methods demonstrate no genotoxic potential-Pub
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0
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113
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August 25, 2024
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N-Nitroso Ruxolitinib
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10
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745
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August 23, 2024
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Suppressing Nitrosamine Drug Substance Related Impurities by Solid Dispersion
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1
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269
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August 22, 2024
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Regulatory Highlights(OPR&D)
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15
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2193
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August 21, 2024
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🇧🇷 Guideline for the control of Nitrosamines Rev. 4
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24
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1479
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August 21, 2024
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Can we bypass confirmatory testing of DP based on Theoretical Calc. of NDSRI's
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8
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1176
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August 20, 2024
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Sitagliptin NTTP nitrosamine impurity maximum active intake level 37ng to 246.7 ng/per day
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29
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5791
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August 19, 2024
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NDSRI of Doxepin
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6
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571
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August 14, 2024
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📅 FDA - CRCG Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products -Event
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1
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958
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August 14, 2024
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AMES Test Study Designs for Nitrosamine Mutagenicity Testing -Pub
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10
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1197
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August 13, 2024
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