N-Nitrosamines Impurities in Pharmaceuticals The Abrupt Challenges that Resulted, the Evolving Science, and the Regulatory Framework-Reference-Cited by-同舟云学术

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N-Nitrosamines Impurities in Pharmaceuticals The Abrupt Challenges that Resulted, the Evolving Science, and the Regulatory Framework

Published:2023-05 Issue:5 Volume:112 Page:1161-1162
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Moser Justin,Schlingemann Jörg^ORCID,Saal Christoph

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Cited by 4 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. A novel and eco-friendly UPLC-ESI-MS method for the quantification of Aceclofenac-NDSRI (Nitroso Drug Substance Related Impurity) from Aceclofenac drug substance and combination formulations;Sustainable Chemistry and Pharmacy;2024-04

2. Regulatory Highlights;Organic Process Research & Development;2024-02-27

3. Synthesis and Trace-Level Quantification of Mutagenic and Cohort-of-Concern Ciprofloxacin Nitroso Drug Substance-Related Impurities (NDSRIs) and Other Nitroso Impurities Using UPLC-ESI-MS/MS─Method Optimization Using I-Optimal Mixture Design;ACS Omega;2024-02-15

4. Formation of N-Nitrosamines by Reaction of Secondary Dialkylamines with Trace Levels of Nitrite in Aqueous Solution: An Automated Experimental and Kinetic Modeling Study Using Di-n-butylamine;Organic Process Research & Development;2023-12-21

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