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An Organic Guide to N-Nitrosamines: Structure, Reactivity, and Role as Contaminants
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1
|
517
|
May 13, 2024
|
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APIC NA Risk Assessment Template
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5
|
3619
|
May 11, 2024
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🇪🇺 EDQM - Certification of suitability to Monographs of the European Pharmacopoeia
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1
|
592
|
April 12, 2024
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EMA - Update Appendix 3: Enhanced Ames Test conditions for N-nitrosamines
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8
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1811
|
April 2, 2024
|
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USP-NF General Notices Revision open for Comments
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0
|
1203
|
March 7, 2024
|
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Updated: IPEC Position Paper on Role of Excipients in Determining N-Nitrosamine Risks for Drug Products
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3
|
1180
|
March 7, 2024
|
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New ICH Guideline Q14
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0
|
497
|
February 12, 2024
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Nitrosamine requirements for probiotics
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4
|
359
|
February 12, 2024
|
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Top 10 deficiencies observed in new CEP applications for chemical purity assessed in 2023
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1
|
641
|
February 9, 2024
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Notifying FDA of a Discontinuance or Interruption in Manufacturing
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0
|
259
|
February 7, 2024
|
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🇪🇺 EMA/409815/2020 Rev.20
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7
|
5380
|
January 31, 2024
|
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Sixth Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry
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4
|
648
|
January 30, 2024
|
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🇬🇧 Medicines: MAH' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing
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2
|
1051
|
January 23, 2024
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European Pharmacopeia - Open for comments 'N-Nitrosamines in active substance and medicinal products'
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0
|
697
|
December 19, 2023
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Health Canada updates guidance(incorrect post)
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2
|
503
|
January 14, 2024
|
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EDQM - European Pharmacopeia - Feedback Nitrosamines
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3
|
1079
|
January 12, 2024
|
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N Nitroso Vildagliptin amide
|
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4
|
1395
|
December 18, 2023
|
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🇰🇷 Korea Drug Review Briefing session on Nitrosamines
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0
|
481
|
December 12, 2023
|
|
NDSRI/ Guidance
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2
|
480
|
December 12, 2023
|
|
Deadline for reporting changes
|
|
2
|
489
|
December 5, 2023
|
|
EMA Q&A Appendix 1 update posted Sept 28,2023
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13
|
1829
|
November 22, 2023
|
|
🇨🇭 Swiss Medic Guidelines
|
|
7
|
1704
|
November 20, 2023
|
|
🇪🇺 EMA - Enhanced AMES test conditions
|
|
0
|
787
|
November 15, 2023
|
|
EMA Q&A Rev. 19 (EMA/409815/2020 Rev.19)
|
|
0
|
1741
|
November 13, 2023
|
|
Revised guidance for J-CTN
|
|
3
|
403
|
November 9, 2023
|
|
Nitrosamine Guidance for Cream and Ophthalmic Solutions
|
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4
|
749
|
November 3, 2023
|
|
🇦🇺 Australia / Nitrosamine impurities in medicines updates
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0
|
730
|
November 2, 2023
|
|
Review of nitrosamine drug substance related impurities (ndsri) in pharmaceutical drugs
|
|
1
|
750
|
October 31, 2023
|
|
🇨🇦 Health Canada Nitrosamine Guide update
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|
5
|
2158
|
October 27, 2023
|
|
Investigation of experiences in handling N-nitrosamine impurities among ZaZiBoNa participating countries -Pub
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|
0
|
523
|
October 16, 2023
|