CHINESE JOURNAL OF DRUG EVALUATION >

2026 , Vol. 43 >Issue 3: 170 - 170-176

DOI: https://doi.org/10.2095-3593.2026.050012

Research Progress on Analytical Methods for Nitrosamine Impurities in Pharmaceutical Products

  • Michael Lee
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  • 1.Qingdao Guoxin Pharmaceutical Co.， Ltd.，Shandong Qingdao 266000，China；
    2.Anqiu Inspection and Testing Center Co.， Ltd.， Shandong Weifang 262100， China；
    3.Weifang Vocational College of Food Science and Technology， School of Food and Biology Engineering， Shandong Weifang 262100， China

Received date: 2025-12-31

  Revised date: 2026-03-17

  Accepted date: 2026-05-19

  Online published: 2026-08-12

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Abstract

Genotoxic impurities are generally acknowledged to have mutagenicity and carcinogenicity， which can cause great damage to DNA. Furthermore， it can seriously endanger the life health of human. Nitrosamine impurities， as the “cohort of concern” impurities of genotoxic impurities， which possesses significant carcinogenic risk， have become one of the research hotspots. This study introduces the categories and formation mechanisms of nitrosamine impurities including small molecular nitrosamine impurities and nitrosamine drug substance related impurities(NDSRI)， and basis for limit establishment of this kind of impurities， and also summarizes the research progress of analytical methods for nitrosamine impurities in pharmaceutical area， including pre-treatment methods and quantitative methods. Pre-treatment methods mainly includes direct dissolution by solvents， filtration， centrifugation， extraction and ultrasonication. Common quantitative methods include gas chromatography， liquid chromatography， gas chromatography tandem mass spectrometry and liquid chromatography tandem mass spectrometry. In addition， NDSRI， as a special kind of nitrosamine impurities， has been highly concerned in recent years. This study introduces the research progress of analytical methods for this kind of impurities individually， in order to provide references for researchers about the selection， development and validation of analytical methods for nitrosamine impurities in pharmaceutical field， such as starting materials， intermediates， drug substances， ingredients， packaging materials and drug products.

Key words： ; font-size:medium; ">Genotoxic impurities； Nitrosamine impurities； Analytical methods； Nitrosamine drug substance related impurities (NDSRI)； Drug safety

Cite this article

Michael Lee . Research Progress on Analytical Methods for Nitrosamine Impurities in Pharmaceutical Products[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2026 , 43(3) : 170 -170-176 . DOI: 10.2095-3593.2026.050012

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