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Determination of migration of common antioxidants and extractable sulfur in medical rubber stoppers to propofol medium/long chain fat emulsion injection by HPLC
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Jie CHENG1, Yan JIANG1, Yi-ting QIU1, Kun REN1, Jin-chi ZHAO2, Tian TIAN1, Luo-hong ZHANG1, *
Chinese Journal of Pharmaceutical Analysis | 2024, 44(2) : 307 - 315
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(2): 307-315
Safety Monitoring
Determination of migration of common antioxidants and extractable sulfur in medical rubber stoppers to propofol medium/long chain fat emulsion injection by HPLC
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Jie CHENG1, Yan JIANG1, Yi-ting QIU1, Kun REN1, Jin-chi ZHAO2, Tian TIAN1, Luo-hong ZHANG1, *
Affiliations
  • 1.Sichuan Institute for Drug Control, Chengdu 610097, China
  • 2.Chengdu Kanghua Biological Products Company Limited, Chengdu 610199, China
Published: 2024-02-29 doi: 10.16155/j.0254-1793.2024.02.14
Outline
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Objective:

To establish a high-performance liquid chromatography (HPLC) method for investigating the extraction of common antioxidants and extractable sulfur in medical rubber stoppers and the migration of antioxidants and extractable sulfur to propofol medium/long chain fat emulsion injection.

Methods:

Waters Symmetry RP18(250 mm×4.6 mm,5 μm) was used as chromatographic column with methanol-acetonitrile -1% acetic acid solution as the mobile phase. Detection wavelength, velocity of flow and column temperature were set to 277 nm, 1 mL·min-1 and 35 ℃.

Results:

Good resolution and linear relationship (r≥0.999 6) in the range of 0.1-20 μg·mL-1 were achieved. This method possesses superior precision, stability, repeatability, and all RSD were less than 5%. The rate of recovery was 93.3%-108.7%, and the RSD was 1.8%-12.5%. The migration of antioxidant BHT was detected in three batches of solution and the content was higher than its corresponding permitted daily exposure (PDE) value, which means there is a large safetyrisk.

Conclusion:

The method represents high sensitivity and is easy to operate, which can effectively detect the migration of antioxidants in propofol medium/long chain fat emulsion injection.

high-performance liquid chromatography (HPLC)  /  propofol medium and long chain fat emulsion injection  /  antioxidants  /  extractable sulfur
Jie CHENG, Yan JIANG, Yi-ting QIU, Kun REN, Jin-chi ZHAO, Tian TIAN, Luo-hong ZHANG. Determination of migration of common antioxidants and extractable sulfur in medical rubber stoppers to propofol medium/long chain fat emulsion injection by HPLC[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (2) : 307 -315 . DOI: 10.16155/j.0254-1793.2024.02.14
Year 2024 volume 44 Issue 2
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doi: 10.16155/j.0254-1793.2024.02.14
  • Online Date:2026-03-13
  • Published:2024-02-29
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History
  • Revised:2023-09-20
Affiliations
    1.Sichuan Institute for Drug Control, Chengdu 610097, China
    2.Chengdu Kanghua Biological Products Company Limited, Chengdu 610199, 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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