Manchuri Krishna Moorthy, Kuril Akhilesh Kumar, Shaik Mahammad Ali, Gopireddy Venkata Subba Reddy, Sultana Naziya
Department of Chemistry, Jawaharlal Nehru Technological University Anantapur, Ananthapuramu, Andhra Pradesh, India.
Department of Pharmacy, Bhagwant University, Ajmer, Rajasthan, India.
Med Gas Res. 2025 Dec 1;15(4):535-543. doi: 10.4103/mgr.MEDGASRES-D-24-00124. Epub 2025 Apr 29.
Controlling or eliminating N-nitrosamine impurities in pharmaceutical products has become a significant challenge for both drug manufacturers and regulatory authorities. This difficulty is particularly pronounced in light of the recent increase in nitrosamine drug substance-related impurities, which have raised concerns about the safety and efficacy of various medications. Additionally, the pharmaceutical industry faces the challenge of developing analytical methods that are not only sensitive and selective but also precise and accurate. These methods are crucial for the reliable quantification of low levels of N-nitrosamine impurities, ensuring compliance with stringent current regulatory guidelines. The intricate nature of detecting these impurities at such low levels necessitates the use of cutting-edge analytical techniques, such as liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry. In light of these challenges, this review article explores the latest regulatory guidelines and analytical methodologies concerning N-nitrosamine impurities in various pharmaceutical products for 2024. Findings from this review article help provide valuable insights for researchers and industry professionals to enhance the safety and quality of pharmaceutical products.
控制或消除药品中的N-亚硝胺杂质已成为制药商和监管机构面临的一项重大挑战。鉴于近期与亚硝胺原料药相关杂质的增加，这一困难尤为突出，这些杂质引发了人们对各种药物安全性和有效性的担忧。此外，制药行业面临着开发不仅灵敏、有选择性，而且精确、准确的分析方法的挑战。这些方法对于可靠地定量低水平的N-亚硝胺杂质、确保符合严格的现行监管指南至关重要。在如此低的水平下检测这些杂质的复杂性需要使用前沿分析技术，如液相色谱-质谱联用和气相色谱-质谱联用。鉴于这些挑战，本文综述探讨了2024年各类药品中N-亚硝胺杂质的最新监管指南和分析方法。本文综述的研究结果有助于为研究人员和行业专业人士提供宝贵见解，以提高药品的安全性和质量。
