[1] | Filgueira G, Filgueira O, Carvalho D M, et al. J Chromatogr B, 2015, 993/994:20 | [2] | Grigoriev A, Nikitina A, Yaroshenko I, et al. J Pharm Biomed Anal, 2016, 131:13 | [3] | Guo Y, Dai J, Qian G, et al. Int J Pharm, 2007, 341(1/2):91 | [4] | Wang D, Jiang K, Yang S, et al. J Chromatogr B, 2011, 879(20):1827 | [5] | Li J A, Wang L, An Y. China Pharmacy, 2009, 20(22):1747 | [5] | 李居安, 王丽, 安瑜. 中国药房, 2009, 20(22):1747 | [6] | Zhu P X, Ding L X, He J J, et al. Chinese Journal of Chromatography, 2012, 30(10):1026 | [6] | 朱培曦, 丁丽霞, 何佳佳, 等. 色谱, 2012, 30(10):1026 | [7] | Sun X Y, Li Q. Journal of Shenyang Pharmaceutical University, 2018, 35(6):469 | [7] | 孙晓岩, 李清. 沈阳药科大学学报, 2018, 35(6):469 | [8] | Zhao X L, Xu J B, Zhang N, et al. Chinese Journal of Pharmaceuticals, 2020, 51(10):1317 | [8] | 赵先亮, 许俊博, 张娜, 等. 中国医药工业杂志, 2020, 51(10):1317 | [9] | Beaulieu N, Curran N M, Graham S J, et al. J Liq Chromatogr, 1991, 14(6):1173 | [10] | Cristobal G R, Jaime G A, Marius V R. Biomed Chromatogr, 2015, 29(2):233 | [11] | Chinese Pharmacopoeia Commission. Pharmacopoeia of the People’s Republic of China, Part IV. Beijing: China Medical Science Press, 2020 | [11] | 国家药典委员会. 中华人民共和国药典2020版, 四部. 北京: 中国医药科技出版社, 2020 | [12] | Zeng H, Wang F, Zhu B, et al. Rapid Commun Mass Spectrom, 2016, 30(15):1771 | [13] | Yu M Y, Li Y J, Ling X. Journal of Pharmaceutical Research, 2017, 36(3):145 | [13] | 于明艳, 李玉杰, 凌霄. 药学研究, 2017, 36(3):145 | [14] | Mei Q, Li Y T, Yang B H, et al. Chinese Journal of Drug Evaluation, 2020, 37(5):353 | [14] | 梅芊, 李倚天, 杨博涵, 等. 中国药物评价, 2020, 37(5):353 | [15] | Liu Y, Li J F, Li N, et al. Chinese Journal of Pharmaceutical Analysis, 2021, 41(1):154 | [15] | 刘暘, 李剑峰, 李宁, 等. 药物分析杂志, 2021, 41(1):154 | [16] | International Council for Harmonization (ICH). ICH Harmonised Guideline, Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk M7 (R1). (2017-03-31). https://database.ich.org/sites/default/files/M7_R1_Guideline.pdf |
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