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Analysis of extractables in rubber with pseudotargeted metabolomics method*
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Hao-wen SHEN1, 2, 5, Meng-qing XIAO3, Hai-tao MENG4, Xiang-yang LENG3, Fang YAN5, **
Chinese Journal of Pharmaceutical Analysis | 2024, 44(4) : 637 - 648
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(4): 637-648
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Analysis of extractables in rubber with pseudotargeted metabolomics method*
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Hao-wen SHEN1, 2, 5, Meng-qing XIAO3, Hai-tao MENG4, Xiang-yang LENG3, Fang YAN5, **
Affiliations
  • 1.Jiangsu Institute of Medical Device Testing, Nanjing 210019, China
  • 2.Key Laboratory of Pharmaceutical Packaging Materials and Compatibility Technologyo of NMPA, Nanjing 210019, China
  • 3.Sciex China Co., Ltd., Shanghai 200050, China
  • 4.Shimadzu (China) Co., Ltd., Shanghai 200233, China
  • 5.School of Pharmacy, China Pharmaceutical University, Nanjing 211198, China
Published: 2024-04-30 doi: 10.16155/j.0254-1793.2024.04.11
Outline
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Objective:

To perform a comprehensive analysis of extractables in rubber by pseudotargeted metabolomics.

Methods:

The quality control(QC) solutions and test solutions were prepared by extracting the six kinds of rubbers with water, pH 2.6 phosphate buffer, pH 9.18 phosphate buffer, and 15% ethanol solution, respectively. The QC solutions were detected by LC-30A ultra performance liquid chromatography-Q TOF-9030 mass spectrometer in ESI+/ESI- mode. The mobile phases were 0.1% formic acid-water and 0.1% formic acid-acetonitrile/0.05% ammonium-water and 0.05% ammonium -5% water-methanol. The separation chromatographic column was Waters Acquity BEH C8/HSS T3. TOF MS and MS/MS DDA scanning modes were used to detect the QC solutions. The scan results of QC solution were processed with MSConvert and MRM-Ion_Pair_Finder software to obtain MRM parameters. The extracts were detected by ExionLC UPLC-Qtrap6500+ mass spectrometer in ESI+/ESI- mode with the same mobile phase and column as before, and Scheduled-MRM scan mode was applied to detect the extracts.

Results:

The 1 399 unknown compounds and 116 known compounds were analyzed. By extraction solution, it was found that pH 9.18 phosphate buffer and 15% ethanol solution could extract more compounds, and 27 compounds with large differences in different extraction solutions were identified. By rubbers, the affinities of different rubbers were determined by 25 differences.

Conclusion:

In this study, the results of the extraction of six rubbers under four extracts are analyzed. There are differences between extracts under different extraction conditions. Analytical methods can be specifically developed for these key variables for quality control follow-up studies to ensure the stability and consistency of drug quality. The variables in different rubbers are also analyzed, which can be used to make a general class determination of unknown rubber samples.

rubber  /  pseudotargeted metabolomics  /  extractable  /  liquid chromatography-tandem mass spectrometry  /  key differential substances  /  quality control  /  class determination
Hao-wen SHEN, Meng-qing XIAO, Hai-tao MENG, Xiang-yang LENG, Fang YAN. Analysis of extractables in rubber with pseudotargeted metabolomics method*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (4) : 637 -648 . DOI: 10.16155/j.0254-1793.2024.04.11
Year 2024 volume 44 Issue 4
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Article Info
doi: 10.16155/j.0254-1793.2024.04.11
  • Online Date:2026-03-13
  • Published:2024-04-30
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History
  • Revised:2024-03-14
Funding
Affiliations
    1.Jiangsu Institute of Medical Device Testing, Nanjing 210019, China
    2.Key Laboratory of Pharmaceutical Packaging Materials and Compatibility Technologyo of NMPA, Nanjing 210019, China
    3.Sciex China Co., Ltd., Shanghai 200050, China
    4.Shimadzu (China) Co., Ltd., Shanghai 200233, China
    5.School of Pharmacy, China Pharmaceutical University, Nanjing 211198, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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