Vikram P R Hemanth, Kandula Dilipkumar Reddy, Gunta Upendra, Kumar Gunjan, Deka Rajashree, Chiriki Devi Sri, Chethan K S, Bannimath Namitha, Yadav Thirumalesh, Beeraka Narasimha Murthy, Gurupadayya B M
Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research (JSSAHER), Mysuru, Karnataka, 570015, India.
Xenone Healthcare Pvt. Ltd, #318, Third Floor, US Complex, Jasola, New Delhi, 110076, India.
Curr Med Chem. 2025;32(6):1065-1081. doi: 10.2174/0109298673322023240829081220.
The discovery of a new class of nitrosamine impurities called nitrosamine drug substance related impurities (NDSRIs) in pharmaceuticals has emerged as a significant challenge for the pharmaceutical sector due to their significant genotoxic and mutagenic effects. Regulatory bodies globally in active collaboration with all the concerned stake holders, are taking effective measures to prevent and control NDSRIs. This comprehensive review on NDSRIs discusses formation pathways, root cause analysis, acceptable intake limits, case studies, control strategies and regulatory responses pertaining to recent NDSRI incidents. This review discusses the novel liquid chromatographic techniques (LC-MS/MS, GC-MS/MS) used to identify and quantify of NDSRIs. This review would aid pharmaceutical professionals, R&D analytical and formulation scientists, and regulatory bodies in gaining deeper insights into the NDSRIs crisis, controlling NDSRIs in drug products, and ensuring their sensitive detection with accurate risk evaluation.
在药品中发现一类名为亚硝胺药物相关杂质（NDSRIs）的新型亚硝胺杂质，因其具有显著的遗传毒性和致突变性，已成为制药行业面临的重大挑战。全球监管机构与所有相关利益攸关方积极合作，正在采取有效措施预防和控制NDSRIs。这篇关于NDSRIs的全面综述讨论了其形成途径、根本原因分析、可接受摄入量限值、案例研究、控制策略以及针对近期NDSRI事件的监管应对措施。本综述讨论了用于识别和定量NDSRIs的新型液相色谱技术（LC-MS/MS、GC-MS/MS）。本综述将有助于制药专业人员、研发分析和制剂科学家以及监管机构更深入地了解NDSRIs危机，控制药品中的NDSRIs，并确保对其进行灵敏检测和准确的风险评估。
