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🖩 CPCA Calculation Tool (excel-based) -Updated
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82
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7694
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April 1, 2024
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4000 Members Milestone 🎉
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18
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679
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November 3, 2023
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Visualization of Categorized Compounds by CPCA
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56
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5845
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February 5, 2024
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🇪🇺 EMA Q&A Rev. 16 EMA/409815/2020 - MAJOR UPDATE
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108
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16478
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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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1887
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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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2431
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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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1477
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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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5569
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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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2153
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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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2702
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July 27, 2023
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🕵️ Toxicology for non-toxicologist Training?
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16
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868
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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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1533
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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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2103
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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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2070
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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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1845
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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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2115
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August 17, 2023
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Autonomous CPCA Web-based calculator FREE
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26
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3225
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November 22, 2023
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Updated EMA-Acceptable intakes (AIs) established for N-nitrosamines
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20
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2886
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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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1730
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December 5, 2023
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FDA/HESI Research Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs
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18
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2778
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June 5, 2023
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EMA Q&A Appendix 1 update posted on Feb. 26, 2024
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11
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1405
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April 9, 2024
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Q&A revision 17 uploaded on EMA page
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12
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1299
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August 25, 2023
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🇨🇦 Health Canada updated the guidance and Appendix 1(March 15, 2024)
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10
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1389
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March 27, 2024
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Adoption of CPCA beyond FDA/ EMA
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9
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820
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January 31, 2024
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🇺🇸 FDA - Fiscal Year 2024 Generic Drug Science and Research Initatives Public Workshop
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30
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1156
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April 18, 2024
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🙋♂️ Citizen Petition to FDA on Sitagliptin
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19
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2188
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December 13, 2023
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Nitrosamines evaluation in transdermal patches
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10
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1311
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March 5, 2024
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Acceptable Intakes (AIs) for 11 Small molecule N-nitrosamines (NAs) -Pub
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17
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1943
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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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14
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1331
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February 27, 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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1658
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November 30, 2023
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Case Studies for CPCA Scoring
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12
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2844
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July 25, 2023
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FDA solicit comments on assessment of NDSRIs
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12
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1789
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July 11, 2023
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A new root cause? NOx
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13
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1168
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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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1348
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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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568
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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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1205
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July 6, 2023
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Automated Total Nitrosamine Analyser
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18
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1103
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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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802
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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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1469
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June 4, 2023
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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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834
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January 19, 2024
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Novartis pauses some trials of cancer drug Kisqali to fix manufacturing
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12
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574
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April 16, 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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3293
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April 2, 2024
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MEGLUMINE (Methylglucamine)
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15
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1744
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March 12, 2024
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A quick (dumb) question
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10
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786
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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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964
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February 8, 2024
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Imidazole is a secondary amine?
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16
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1632
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January 30, 2024
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Low nitrite excipients
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9
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1108
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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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941
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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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1457
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January 5, 2024
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Risk Analysis of Colorants and Flavorings in Pharmaceutical Formulations
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9
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611
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July 21, 2023
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