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🖩 CPCA Calculation Tool (excel-based) -Updated
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82
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8073
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April 1, 2024
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4000 Members Milestone 🎉
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18
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756
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November 3, 2023
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Visualization of Categorized Compounds by CPCA
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58
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6231
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May 3, 2024
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🇪🇺 EMA Q&A Rev. 16 EMA/409815/2020 - MAJOR UPDATE
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108
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17422
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September 12, 2023
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📚 OPRD Special Issue on Nitrosamines -Pub
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13
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1953
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January 23, 2024
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Updated FDA list of published limits
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15
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2605
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December 15, 2023
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EMA Q&A Appendix 1 update posted Sept 28,2023
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13
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1512
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November 22, 2023
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🇺🇸 FDA - Recommended Acceptable Intake Limits for NDSRIs Guidance for Industry
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47
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5810
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September 20, 2023
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Nitrosamines: A new systematic review
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11
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2443
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April 14, 2024
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FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
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11
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2814
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July 27, 2023
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Potential Topic for an event concerning obtaining the right level of Nitrosamine Risk Assessment information from your CMOs
Hi My Fearless Nitrosaters,
I wanted to ask a question to determine if people in the Exchange would find value in an event if the topic was to cover the following:
“Benchmarking on obtaining more robust nitrosamine ass…
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19
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804
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May 16, 2024
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Autonomous CPCA Web-based calculator FREE
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28
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3636
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May 2, 2024
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🕵️ Toxicology for non-toxicologist Training?
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16
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885
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June 27, 2023
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Free Webinar: Nitrosamines in Drug Products
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12
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1620
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November 16, 2023
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New paper - Use of molar, instead of weight-based, safety limits
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16
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2178
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January 7, 2024
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CPCA is now included in the updated version of Health Canada’s Guidance on nitrosamine impurities
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15
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2131
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October 13, 2023
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Redefining Nitrosamine Risks: A Fresh Perspective on Pharmaceuticals -Pub
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16
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1918
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December 17, 2023
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🗓 Nitrosamines Conversation Event w/ Dr. Raphael Nudelman
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16
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2186
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August 17, 2023
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EMA Q&A Appendix 1 update posted on Feb. 26, 2024
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28
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2013
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May 16, 2024
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Updated EMA-Acceptable intakes (AIs) established for N-nitrosamines
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20
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3137
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January 29, 2024
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Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
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11
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1850
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December 5, 2023
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Nitrosamines evaluation in transdermal patches
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10
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1451
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March 5, 2024
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Q&A revision 17 uploaded on EMA page
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12
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1335
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August 25, 2023
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🇺🇸 FDA - Fiscal Year 2024 Generic Drug Science and Research Initatives Public Workshop
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31
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1335
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May 14, 2024
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🇨🇦 Health Canada updated the guidance and Appendix 1(March 15, 2024)
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10
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1637
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March 27, 2024
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🙋♂️ Citizen Petition to FDA on Sitagliptin
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19
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2359
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December 13, 2023
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Adoption of CPCA beyond FDA/ EMA
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9
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848
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January 31, 2024
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N-nitroso-amlodipine ; N-nitroso-felodipine ; synthesis not successfull but still listed by FDA and EMA as NDSRIs
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11
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1807
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November 30, 2023
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Acceptable Intakes (AIs) for 11 Small molecule N-nitrosamines (NAs) -Pub
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17
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2088
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March 28, 2024
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🇺🇸 FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3
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15
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1666
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May 12, 2024
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Case Studies for CPCA Scoring
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12
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3057
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July 25, 2023
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Nitrosamine AI limit calculation if the risk is coming only out of excipients'
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11
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773
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May 13, 2024
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A new root cause? NOx
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13
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1254
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November 17, 2023
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Aromatic nitrogen "Is it possible for aromatic nitrogen to convert nitrosamine?"- Indole
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10
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1458
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February 2, 2024
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Establishment of Acceptable Intakes, framework
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12
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578
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July 12, 2023
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Proposed approach to Temporary Acceptable intake Limits for NDSRIs
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10
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1223
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July 6, 2023
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Automated Total Nitrosamine Analyser
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18
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1155
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November 19, 2023
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Korean drug manufacturers are taking voluntary action by recalling or suspending the sales of tamsulosin, citing potential NDSRI impurity, N-Nitroso-tamsulosin concern
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19
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912
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April 18, 2024
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Establishing acceptable intakes (AI) for complex nitrosamines (NDSRIs)
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16
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1504
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June 4, 2023
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Novartis pauses some trials of cancer drug Kisqali to fix manufacturing
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12
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747
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April 16, 2024
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⚖️ Risk assessment not strong enough, specifically on related impurities containing secondary amine
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11
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883
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January 19, 2024
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AMES Test Study Designs for Nitrosamine Mutagenicity Testing -Pub
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9
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614
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May 10, 2024
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Sitagliptin NTTP nitrosamine impurity maximum active intake level 37ng to 246.7 ng/per day
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26
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3565
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April 2, 2024
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MEGLUMINE (Methylglucamine)
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15
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1839
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March 12, 2024
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A quick (dumb) question
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10
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832
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January 22, 2024
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🗃 Poll: Interest of having a commercial directory here in the community?
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13
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1017
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February 8, 2024
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Low nitrite excipients
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9
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1262
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April 12, 2024
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N-nitroso Des-methyl Dapoxetine
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12
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984
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May 31, 2023
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N-nitroso Torasemide Impurity formation and control
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23
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1497
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January 5, 2024
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Enhanced Ames Test Conditions for N-nitrosamines (Q&A Rev.16)
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9
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2019
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September 13, 2023
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