[1] 冯美彦. 浅析化学药品注射剂一致性评价包材相容性研究的法规要求[J]. 科技风, 2022(1):157
FENG MY. Analysis of the regulatory requirements for the compatibility study of packaging materials for the consistency evaluation of chemical injection [J]. Technol Wind, 2022 (1):157
[2] 刘伟, 王志嘉, 赵海波, 等. 门冬氨酸鸟氨酸注射液与中硼硅玻璃安瓿相容性研究[J]. 沈阳药科大学学报, 2022, 39(8):944
LIU W, WANG ZJ, ZHAO HB, et al. The compatibility of ornithine aspartate injection and neutral borosilicate glass ampoule bottle. [J]. J Shenyang Pharm Univ, 2022, 39(8):944
[3] MAITHANI M, RATURI R, SHARMA P, et al. Elemental impurities in pharmaceutical products adding fuel to the fire [J]. Regul Toxicol Pharm, 2019, 108: 104435
[4] MITTAL M, KUMAR K. ICP-MS: analytical method for identification and detection of elemental impurities[J]. Curr Drug Discov Technol, 2017, 14(2):106
[5] ICH Q3D Guideline for elemental impurities [S]. 2018
[6] 耿悦, 宋芸峰, 沈杰, 等. ICP-MS法测定注射用头孢美唑钠中31种元素杂质的含量[J]. 药学与临床研究, 2022, 30(5):403
GENG Y, SONG YF, SHEN J, et al. ICP-MS determination of 31 impurity elements in cefmetazole sodium for injection [J]. Pharm Clin Res, 2022, 30(5):403
[7] 杨建英, 黄让明. 微波消解-电感耦合等离子体原子发射光谱法同时测定儿童唇膏产品中19种有害元素[J]. 化学分析计量, 2022, 31(8):13
YANG JY, HUANG RM. Simultaneous determination of 19 harmful elements in children's lipstick products by microwave digestion inductively coupled plasma atomic emission spectrometry [J]. Chem Anal Metrol, 2022, 31(8):13
[8] 朱俐, 赵瑜, 尹利辉, 等. 电感耦合等离子体原子发射光谱法和电感耦合等离子体质谱法检测药品中元素杂质的研究进展[J]. 理化检验-化学分册, 2022, 58(3):361
ZHU L, ZHAO Y, YIN LH, et al. Research progress of determination of elemental impurities in drugs by ICP-AES and ICP-MS [J]. Phys Test Chem Anal Part B:Chem Anal,2022, 58(3):361
[9] 胡淑君, 叶秀金, 郭雅娟, 等. 电感耦合等离子体-质谱法测定原淀粉中的14种杂质元素[J]. 华西药学杂志, 2022, 37(4):448
HU SJ, YE XJ, GUO YJ, et al. Determination of 14 elemental impurities in starch by ICP-MS [J]. West China J Pharm Sci, 2022, 37(4):448
[10] PLUHAEK T, RUCKA M. A direct LA-ICP-MS screening of elemental impurities in pharmaceutical products in compliance with USP and ICH-Q3D[J]. Anal Chim Acta, 2019, 1078:1
[11] 欧阳婷, 曾祥盛, 罗恒真, 等. 电感耦合等离子体质谱法测定拉考沙胺注射液中10种杂质元素[J]. 理化检验-化学分册, 2020, 56(2):211
OUYANG T, ZENG XS, LUO HZ, et al. ICP-MS determination of 10 impurity elements in lacosamide injection [J]. Phys Test Chem Anal Part B:Chem Anal, 2020, 56(2):211
[12] CERVEIRA C, HERMANN PRS, PEREIRA JSF, et al. Evaluation of microwave-assisted ultraviolet digestion method for rice and wheat for subsequent spectrometric determination of As, Cd, Hg and Pb [J]. J Food Compost Anal, 2020, 92(9):103585
[13] 钱胡月, 宋立平, 彭燕, 等, 电感耦合等离子体质谱法测定布洛肾素片中的1类和2A类元素[J]. 华西药学杂志, 2022, 37(5):552
QIAN HY, SONG LP, PENG Y, et al. Determination of class 1 and 2A elements in Ibuprofen renin tablets ICP-MS [J]. West China J Pharm Sci, 2022, 37(5): 552
[14] 徐佳慧, 韩良, 马壹文, 等. ICP-MS 快速筛查多种注射剂中的元素杂质[J]. 中南药学, 2019, 17(9):1412
XI JH, HAN L, MA YW, et al. Rapid screening of element impurities in various injections by inductively coupled plasma mass spectrometry[J]. Cent South Pharm, 2019, 17(9):1412
[15] 徐文峰, 金鹏飞, 徐硕, 等. 电感耦合等离子质谱在药物分析中的应用[J]. 药物分析杂志, 2017, 37(12):2123
XU WF, JIN PF, XU S, et al. Application of ICP-MS in pharmaceutical analysis [J]. Chin J Pharm Anal, 2017, 37(12):2123
[16] 李忠, 吴杨, 聂金菊, 等. 基体匹配-电感耦合等离子体质谱法测定钆喷酸葡胺中24种元素杂质[J]. 中国医药工业杂志, 2022, 53(9):1311
LI Z, WU Y, NIE JJ, et al. Determination of twenty-four elemental impurities in gadopentetate dimeglumine by ICP-MS with matrix-matching method [J]. Chin J Pharm, 2022, 53(9):1311
[17] 郑明, 叶拥军, 卜美媛, 等. 电感耦合等离子体质谱法测定甘油(供注射用)中7种元素杂质含量[J]. 中国药师, 2020, 23(3):593
ZHENG M, YE YJ, BU MY, et al. Determination of 7 elemental impurities in glycerol for injection by ICP-MS[J]. China Pharm,2020, 23(3):593
[18] 李文莉, 汪汝沛, 徐燕. 电感耦合等离子体质谱法测定硫辛酸注射液中6种杂质元素含量[J]. 四川生理科学杂志, 2020, 42(4):388
LI WL, WANG RP, XU Y. Determination of 6 elemental impurities in Alpha lipoic acid injection by inductivly coupled plasma mass spectrometry [J]. Sichuan J Physiol Sci, 2020, 42(4):388
[19] BAKIRHAN NK, OZKAN SA. Recent advances and future perspectives in pharmaceutical analysis[J]. Curr Pharm Anal, 2019, 16(1):2
