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XIAN Zhiran, SUN Chunmeng, LUO Xuefang, ZHONG Wenying. Profiling of genotoxic impurities in a lidocaine hydrochloride injection[J]. Journal of China Pharmaceutical University, 2020, 51(4): 466-471. DOI: 10.11665/j.issn.1000-5048.20200412
Citation: XIAN Zhiran, SUN Chunmeng, LUO Xuefang, ZHONG Wenying. Profiling of genotoxic impurities in a lidocaine hydrochloride injection[J]. Journal of China Pharmaceutical University, 2020, 51(4): 466-471. DOI: 10.11665/j.issn.1000-5048.20200412
shu

Profiling of genotoxic impurities in a lidocaine hydrochloride injection

  • 1.

    Drug Quality Research Center, College of Science, China Pharmaceutical University

  • 2.

    School of Pharmacy, China Pharmaceutical University, China

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  • Received Date: March 19, 2020
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    • References (20)
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    Koujitani T., Yasuhara K., Kobayashi H., et al. Tumor‐promoting activity of 2,6‐dimethylaniline in a two‐stage nasal carcinogenesis model in N‐bis(2‐hydroxypropyl) nitrosamine‐treated rats[J]. Cancer Lett, 1999,142(2):161-171.
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    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Trepartite Guideline: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk M7(R1) [S/OL]. (2017-05-01) [2019-01-28]. https://www.ich.org/fileadmin/.
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