Topics tagged NDSRI

Topic	Replies	Views	Activity
AI for NDSRIs with positive EAT and/or in-vivo mutagenicity study - FDA position? Limits of Nitrosamines Limits , FDA , NDSRI	2	469	November 9, 2023
Vilazodone Nitrosamine Confirmatory Testing & Analytical Challenges Drug_Substance_APIs , NDSRI	0	324	October 31, 2023
Review of nitrosamine drug substance related impurities (ndsri) in pharmaceutical drugs Guidance, Documents, Resources NDSRI	1	594	October 31, 2023
Personal perspective on N-Nitrosamines and recent revision of guidelines Events / Workshops / Webinars NDSRI , Excipients	7	654	October 27, 2023
Reflections on the Impact of Nitrosamine Drug Substance Related Impurities Guidance, Documents, Resources NDSRI	0	342	October 20, 2023
CPCA is now included in the updated version of Health Canada’s Guidance on nitrosamine impurities Guidance, Documents, Resources NDSRI	15	2126	October 13, 2023
NDSRIs: Analytical Challenges/ Desafios Analíticos Confirmatory Testing & Analytical Challenges NDSRI	0	477	October 11, 2023
Variation requirements Root Causes Drug_Substance_APIs , NDSRI , Storage_Stability , Excipients	2	385	October 2, 2023
关于2023药物杂质控制国际交流会的资讯 Nitrosamines in the News NDSRI	1	384	September 29, 2023
🇺🇸 FDA - Recommended Acceptable Intake Limits for NDSRIs Guidance for Industry Guidance, Documents, Resources NDSRI , Drug_Substance_APIs	47	5783	September 20, 2023
Nitrosamine in DS and DP specifications Limits of Nitrosamines Drug_Substance_APIs , NDSRI	2	704	September 20, 2023
Apixaban Drug Substance-Related Impurities (NDSRIs) Root Causes Manufacturing , NDSRI , Excipients , Drug_Substance_APIs	3	1034	September 15, 2023
🇪🇺 EMA Q&A Rev. 16 EMA/409815/2020 - MAJOR UPDATE Guidance, Documents, Resources NDSRI , Drug_Substance_APIs	108	17302	September 12, 2023
DP Method transfer and verification Confirmatory Testing & Analytical Challenges NDSRI	8	569	August 31, 2023
Optimized method development strategies for the quantification of small and complex N-nitrosamines impurities Events / Workshops / Webinars NDSRI	0	415	August 25, 2023
Approaches and Considerations for the Investigation and Synthesis of N‑Nitrosamine Drug Substance-Related Impurities (NDSRIs) New Scientific Knowledge & Development NDSRI	0	543	August 23, 2023
Nitrosaminas: Estrutura química vs Potencial carcinogênico N-nitrosamines Chemistry Drug_Substance_APIs , NDSRI	3	475	August 23, 2023
N-Nitroso N-Desmethyl Nefopam Limits of Nitrosamines NDSRI	4	691	August 18, 2023
Total impurities limit if more than one nitrosamine impurities are observed in product Limits of Nitrosamines Manufacturing , NDSRI , Drug_Substance_APIs , FDA , Live-Conversations	4	537	August 14, 2023
Planilha CPCA na prática Guidance, Documents, Resources NDSRI , Drug_Substance_APIs	0	318	August 6, 2023
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities Events / Workshops / Webinars Excipients , FDA , NDSRI , Drug_Substance_APIs , Manufacturing	11	2804	July 27, 2023
Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies Risk Assessment Strategy / Tools & Technology NDSRI	3	803	July 26, 2023
Case Studies for CPCA Scoring Limits of Nitrosamines NDSRI	12	3031	July 25, 2023
NDSRIs: Atualizações e Desafios Guidance, Documents, Resources Manufacturing , Drug_Substance_APIs , NDSRI	0	390	July 24, 2023
Forced degradation: predicting nitrosamine formation New Scientific Knowledge & Development NDSRI , Drug_Substance_APIs	8	1270	July 20, 2023
😞 Aripiprazole is not approvable since 'major objections' have been identified Nitrosamines in the News NDSRI	6	664	July 18, 2023
Strategies for Mitigating In-Source Fragmentation in NDSRI Analysis using LC-MS Confirmatory Testing & Analytical Challenges NDSRI , Drug_Substance_APIs	2	1261	July 3, 2023
The 18 ng/day default for NDSRIs should be re-visited? Limits of Nitrosamines NDSRI , Drug_Substance_APIs	8	831	June 14, 2023
FDA solicit comments on assessment of NDSRIs Guidance, Documents, Resources NDSRI	12	1826	July 11, 2023
Formation of N-nitroso Fluconazole and Related Triazole-Imidazole APIs Guidance, Documents, Resources NDSRI , Drug_Substance_APIs , Storage_Stability	4	878	June 9, 2023