VALIDATION OF A HEADSPACE GAS CHROMATOGRAPHY METHOD FOR VOLATILE RESIDUAL SOLVENTS IDENTIFICATION IN RADIOPHARMACEUTICALS

被引：0
|
作者：
Tudoroiu-cornoiu, Maria-Roxana [1 ,2 ]
Chilug, Elena Livia [2 ]
Ion, Ion [1 ]
Niculae, Dana [2 ]
机构：
[1] Natl Univ Sci & Technol Politehn Bucharest, Fac Chem Engn & Biotechnol, Doctoral Sch Appl Chem & Mat Sci, Bucharest, Romania
[2] Horia Hulubei Natl Inst R&D Phys & Nucl Engn, Magurele, Romania
来源：
UNIVERSITY POLITEHNICA OF BUCHAREST SCIENTIFIC BULLETIN SERIES B-CHEMISTRY AND MATERIALS SCIENCE | 2024年 / 86卷 / 04期
关键词：
residual solvent; chemical purity; HS-GC; validation; Cu-64]Cu- DOTA-NT;
D O I：
暂无
中图分类号：
O6 [化学];
学科分类号：
0703 ;
摘要：
The following study presents the development and validation of a headspace gas chromatography (HS-GC) analytical method for determining five residual solvents, frequently encountered in radioactive drugs. Measurement of residual solvents is a critical step in the testing and release of pharmaceutical products. The method demonstrated high accuracy and precision, being specific and fast, under the regulations of the European Pharmacopoeia.
引用
收藏
页码：119 / 130
页数：12
相关论文
共 50 条
  • [31] Determination of residual organic solvents in flunixin meglumine raw material by headspace gas chromatography
    Hu Huilian
    CHINESE JOURNAL OF CHROMATOGRAPHY, 2012, 30 (01) : 99 - 102
  • [32] Simultaneous determination of seven residual solvents in bovis calculus artifactus by headspace gas chromatography
    Chi Shuyao
    Wu Dike
    Sun Jinhong
    Ye Ruhan
    Wang Xiaoyan
    CHINESE JOURNAL OF CHROMATOGRAPHY, 2014, 32 (05) : 553 - 557
  • [33] Quantification of Residual Organic Solvents in Clobetasol Propionate using Headspace Capillary Gas Chromatography
    Shi, Xiaoyi
    Li, Shuai
    Li, Zhao
    Zeng, Hangri
    Liu, Yi
    Lan, Wen
    Liu, Yanming
    Zheng, Jinfeng
    CHROMATOGRAPHIA, 2024, 87 (04) : 195 - 202
  • [34] Use of ionic liquids as headspace gas chromatography diluents for the analysis of residual solvents in pharmaceuticals
    Nacham, Omprakash
    Ho, Tien D.
    Anderson, Jared L.
    Webster, Gregory K.
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2017, 145 : 879 - 886
  • [35] Quantification of Residual Organic Solvents in Clobetasol Propionate using Headspace Capillary Gas Chromatography
    Xiaoyi Shi
    Shuai Li
    Zhao Li
    Hangri Zeng
    Yi Liu
    Wen Lan
    Yanming Liu
    Jinfeng Zheng
    Chromatographia, 2024, 87 : 195 - 202
  • [36] Determination of multiple residual solvents in ibandronate sodium using headspace-gas chromatography
    Zhou Ran
    Wang Fei
    Lin Jiarui
    Jia Meng
    Wang Yan
    CHINESE JOURNAL OF CHROMATOGRAPHY, 2024, 42 (05) : 481 - 486
  • [37] Unknown residual solvents identification in drug products by headspace solid phase microextraction gas chromatography-mass spectrometry
    C. C. Camarasu
    Chromatographia, 2002, 56 : S131 - S135
  • [38] Development and Validation of a Gas Chromatography Method for Quality Control of Residual Solvents in Azilsartan Bulk Drugs
    Guan, Jin
    Min, Jie
    Yan, Feng
    Xu, Wen-Ya
    Shi, Shuang
    Wang, Si-Lin
    JOURNAL OF CHROMATOGRAPHIC SCIENCE, 2017, 55 (04) : 393 - 397
  • [39] Development and Validation of a Method for Assay of Residual Organic Solvents in Kemantane Substance by Gas Liquid Chromatography
    Tolkacheva, A. V.
    Grushevskaya, L. N.
    Avdyunina, N. I.
    Pyatin, B. M.
    Prokof'eva, V. I.
    Gaevaya, L. M.
    Zaitseva, N. M.
    PHARMACEUTICAL CHEMISTRY JOURNAL, 2015, 49 (01) : 59 - 64
  • [40] Development and Validation of a Method for Assay of Residual Organic Solvents in Kemantane Substance by Gas Liquid Chromatography
    A. V. Tolkacheva
    L. N. Grushevskaya
    N. I. Avdyunina
    B. M. Pyatin
    V. I. Prokof’eva
    L. M. Gaevaya
    N. M. Zaitseva
    Pharmaceutical Chemistry Journal, 2015, 49 : 59 - 64
12345