Nitrosamines Exchange

Topic	Replies	Views	Activity
Webinars (available on demand) Events / Workshops / Webinars	0	530	June 20, 2023
Losartan azide impurity confirmed as not an in vivo mutagen compound Guidance, Documents, Resources Drug_Substance_APIs	5	1663	June 20, 2023
Guideline ANVISA - Brazil: version 3, updates Guidance, Documents, Resources Drug_Substance_APIs	8	3454	June 19, 2023
Limits of nitrosamine impurity below 10 ppm in drug products Limits of Nitrosamines	0	704	June 19, 2023
Oxidation of Nitrite during Ion Chromatographic Analysis? Confirmatory Testing & Analytical Challenges	2	528	June 16, 2023
pH modification N-nitrosamines Chemistry	5	827	June 16, 2023
Limits for N-nitroso vortioxetine Limits of Nitrosamines	3	1314	June 15, 2023
Fiscal Year (FY) 2023 Generic Drug Science and Research Initiatives Public Workshop May 11-12, 2023 Events / Workshops / Webinars FDA	3	627	June 15, 2023
The 18 ng/day default for NDSRIs should be re-visited? Limits of Nitrosamines NDSRI , Drug_Substance_APIs	8	923	June 14, 2023
FDA solicit comments on assessment of NDSRIs Guidance, Documents, Resources NDSRI	12	1936	July 11, 2023
CMDh mandated the SWP/NcWP for AI derivations of N-nitrosamines Limits of Nitrosamines	6	963	June 10, 2023
Formation of N-nitroso Fluconazole and Related Triazole-Imidazole APIs Guidance, Documents, Resources NDSRI , Drug_Substance_APIs , Storage_Stability	4	1313	June 9, 2023
Nitrosamines from tertiary amines in azabicycles Root Causes	4	404	June 9, 2023
IPEC Nitrosamine Questionnaire Q&A Excipients Excipients Excipients	6	1184	June 8, 2023
The predecesor to ICH M7 Guidance, Documents, Resources	0	602	June 7, 2023
Impact of Different API Salts N-nitrosamines Chemistry	4	612	June 7, 2023
Evidence on the Carcinogenicity of Nitrite in Combination with Amines or Amides N-nitrosamines Chemistry NDSRI , ames , Drug_Substance_APIs	0	527	June 6, 2023
FDA/HESI Research Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs Events / Workshops / Webinars	18	3381	June 5, 2023
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products Root Causes Excipients	1	930	June 5, 2023
FDA/HESI Collaborative Roadmap: Advancing Hazard and Risk Assessment of Nitrosamine Impurities in Pharmaceuticals Limits of Nitrosamines NDSRI , ames , FDA , Drug_Substance_APIs	2	925	June 5, 2023
Establishing acceptable intakes (AI) for complex nitrosamines (NDSRIs) Limits of Nitrosamines NDSRI	16	1780	June 4, 2023
Fda行业指南中总亚硝胺杂质含量要求 Limits of Nitrosamines Drug_Substance_APIs	1	684	June 2, 2023
Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses Limits of Nitrosamines	2	808	June 1, 2023
Secondary amine Risk Assessment Guidance, Documents, Resources	9	1163	June 1, 2023
N-nitroso Des-methyl Dapoxetine Limits of Nitrosamines FDA , Manufacturing , Drug_Substance_APIs	12	1241	May 31, 2023
Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities (NDSRIs) New Scientific Knowledge & Development NDSRI	1	883	May 31, 2023
👨‍💻 Nitrosamines Analysis in Solvents by GC-MS/MS Analytical Methods Hub Analytical-Hub	5	3955	May 28, 2023
✌️Need✌️ your input on NDSRIs challenges? Limits of Nitrosamines	33	3220	May 26, 2023
Nitrosamine in Peptides Guidance, Documents, Resources Drug_Substance_APIs	2	848	May 26, 2023
FDA Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays Limits of Nitrosamines FDA , NDSRI , ames , NDSRIs	1	1542	May 24, 2023