Anybody have a working method for NTTP in Sitagliptin?
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3
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1051
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April 6, 2023
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Use of Multiple 3rd Party Laboratories for Testing
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1
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583
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April 5, 2023
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The true role of NitrXtes in NDSRIs?
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2
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454
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April 3, 2023
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Theoretical 'Purge Factor'
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10
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2268
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March 31, 2023
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Any method out there for N-Nitrosomethylphenidate
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0
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409
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March 31, 2023
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Korea FDA just published a compilation of analytical methods document!
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13
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2693
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March 31, 2023
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Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules due to the presence of a NDSRI, N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level
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5
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990
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March 30, 2023
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N-Nitrosamines and their precursors in wastewater effluents from selected industries in Spain -Pub
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0
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322
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March 29, 2023
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Unofficial/official surrogates for read-across
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5
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2095
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March 27, 2023
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NDMA formation Due to Active Ingredient Degradation and Nitrite Traces in Drug Product
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0
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759
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March 24, 2023
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Computational Prediction of Metabolic α-Carbon Hydroxylation Potential of N-Nitrosamines: Overcoming Data Limitations for Carcinogenicity Assessment
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5
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894
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March 23, 2023
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Officially used surrogates for read-across method
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14
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2915
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March 23, 2023
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LoQ of 0.03 ppm
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5
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1340
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March 15, 2023
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NDSRI complex nitrosamine Accetable Intake methodology harmonisation by regulators may be followed in Early 2024
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1
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974
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March 14, 2023
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Limit for Nitroso Atenolol
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6
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1581
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March 14, 2023
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3-year work plan for EMA Nitrosamine Safety Operational Expert Group
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0
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544
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March 11, 2023
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The Landscape of Small and Drug Substance Related Nitrosamines in Pharmaceuticals
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10
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1823
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March 8, 2023
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U̶p̶c̶o̶m̶i̶n̶g̶ Nitrosamine Special Issue of JPS
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3
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1969
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March 7, 2023
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Testing of finished product when working with hard gelatin capsules
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2
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760
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March 6, 2023
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Solid State Kinetics of Nitrosation Using Native Sources of Nitrite -Pub
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1
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1088
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March 6, 2023
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UHPLC-APCI-TQ-MS analytical method capable of quantifying eight nitrosamine impurities from five different Metformin Formulations -Pub
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1
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913
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March 2, 2023
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确定DNSRI的限度需要同时进行Ames和致癌性实验吗?
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4
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563
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March 2, 2023
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Current threat of nitrosamines in pharmaceuticals and scientific strategies for risk mitigation -Pub
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0
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960
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February 7, 2023
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A Survey of Industrial N-nitrosamine Discharges in Switzerland -Pub
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0
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329
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March 1, 2023
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Health Canada - Guideline: Quality (CMC) Draft Guidance - New Drug Submissions & Abbreviated New Drug Submissions
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0
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1207
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February 27, 2023
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FDA updated compliance program guidance por inspections
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1
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711
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February 27, 2023
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👋🏻 Fantastic Regulatory Update Europe, US, LATAM
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8
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2402
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February 25, 2023
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Formation of Dialkyl-N-nitrosamines in Aqueous Solution: An Experimental Validation of a Conservative Predictive Model and a Comparison of the Rates of Dialkyl and Trialkylamine Nitrosation
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6
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1292
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February 25, 2023
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EMA Nitrosamine Q&A Rev14 published
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6
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1291
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February 23, 2023
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N-nitroso-propranolol?
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18
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2633
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February 22, 2023
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