Topics tagged NDSRI

Topic	Replies	Views	Activity
DP Method transfer and verification Confirmatory Testing & Analytical Challenges NDSRI	8	700	August 31, 2023
Optimized method development strategies for the quantification of small and complex N-nitrosamines impurities Events / Workshops / Webinars NDSRI	0	454	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	610	August 23, 2023
Nitrosaminas: Estrutura química vs Potencial carcinogênico N-nitrosamines Chemistry Drug_Substance_APIs , NDSRI	3	535	August 23, 2023
N-Nitroso N-Desmethyl Nefopam Limits of Nitrosamines NDSRI	4	863	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	624	August 14, 2023
Planilha CPCA na prática Guidance, Documents, Resources NDSRI , Drug_Substance_APIs	0	370	August 6, 2023
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities Events / Workshops / Webinars Excipients , FDA , NDSRI , Drug_Substance_APIs , Manufacturing	11	3187	July 27, 2023
Case Studies for CPCA Scoring Limits of Nitrosamines NDSRI	12	3503	July 25, 2023
NDSRIs: Atualizações e Desafios Guidance, Documents, Resources Manufacturing , Drug_Substance_APIs , NDSRI	0	434	July 24, 2023
Forced degradation: predicting nitrosamine formation New Scientific Knowledge & Development NDSRI , Drug_Substance_APIs	8	1536	July 20, 2023
😞 Aripiprazole is not approvable since 'major objections' have been identified Nitrosamines in the News NDSRI	6	788	July 18, 2023
Strategies for Mitigating In-Source Fragmentation in NDSRI Analysis using LC-MS Confirmatory Testing & Analytical Challenges NDSRI , Drug_Substance_APIs	2	1677	July 3, 2023
The 18 ng/day default for NDSRIs should be re-visited? Limits of Nitrosamines NDSRI , Drug_Substance_APIs	8	887	June 14, 2023
FDA solicit comments on assessment of NDSRIs Guidance, Documents, Resources NDSRI	12	1915	July 11, 2023
Formation of N-nitroso Fluconazole and Related Triazole-Imidazole APIs Guidance, Documents, Resources NDSRI , Drug_Substance_APIs , Storage_Stability	4	1038	June 9, 2023
Evidence on the Carcinogenicity of Nitrite in Combination with Amines or Amides N-nitrosamines Chemistry NDSRI , ames , Drug_Substance_APIs	0	469	June 6, 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	873	June 5, 2023
Establishing acceptable intakes (AI) for complex nitrosamines (NDSRIs) Limits of Nitrosamines NDSRI	16	1688	June 4, 2023
Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities (NDSRIs) New Scientific Knowledge & Development NDSRI	1	805	May 31, 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	1433	May 24, 2023
Mutagenic impurities in pharmaceuticals: A critical assessment of the cohort of concern with a focus on N-nitrosamines Limits of Nitrosamines NDSRI	2	948	May 23, 2023
Nitroso Furosemide Limits of Nitrosamines NDSRI	1	772	May 20, 2023
A Consideration of the Extent That Tertiary Amines Can Form N-Nitroso Dialkylamines in Pharmaceutical Products Risk Assessment Strategy / Tools & Technology NDSRI	1	1095	April 25, 2023
EFPIA Position paper for NDSRIs of beta-blockers and beta-agonists / ACE inhibitors / dihydropyridine Limits of Nitrosamines NDSRI	1	1223	April 24, 2023
Drawing a line: Where might the cohort of concern end? New Scientific Knowledge & Development NDSRI	5	955	April 18, 2023
Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules due to the presence of a NDSRI, N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level Nitrosamines in the News NDSRI	5	925	March 30, 2023
Unofficial/official surrogates for read-across Limits of Nitrosamines NDSRI	5	1954	March 27, 2023
Formation of Dialkyl-N-nitrosamines in Aqueous Solution: An Experimental Validation of a Conservative Predictive Model and a Comparison of the Rates of Dialkyl and Trialkylamine Nitrosation Risk Assessment Strategy / Tools & Technology NDSRI	6	1151	February 25, 2023
Pfizer Japan to Curb Shipments and Recall Amoxapine over Carcinogen Risks Nitrosamines in the News NDSRI	3	642	November 10, 2022