Formation of nitrosamine impurities: Discussion and advanced method development and validation using LC-MS/MS for their detection
SAGE University, Indore.
Review
World Journal of Biology Pharmacy and Health Sciences, 2024, 20(03), 385-389.
Article DOI: 10.30574/wjbphs.2024.20.3.1016
Publication history:
Received on 02 November 2024; revised on 12 December 2024; accepted on 14 December 2024
Abstract:
Nitrosamine impurities, known for their genotoxic and carcinogenic potential, have emerged as critical concerns in pharmaceutical manufacturing. Their presence in various drug substances and products has led to stringent regulatory actions globally. This report explores the formation mechanisms of nitrosamine impurities, including the subset of nitrosamine drug substance-related impurities (NDSRIs), which arise from API-specific interactions. Advanced analytical techniques such as LC-MS/MS, GC-MS/MS, and HRMS are reviewed for their efficacy in detecting and quantifying these impurities. The report also emphasizes regulatory frameworks and discusses comprehensive risk assessment strategies. By combining robust analytical methodologies and harmonized guidelines, the industry can ensure the safety and efficacy of pharmaceutical products.
Keywords:
Nitrosamine impurities; NDSRIs; LC-MS/MS; GC-MS/MS; Method validation; Regulatory compliance; Pharmaceutical safety
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Copyright © 2024 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0