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Determination of 25 elements impurities in alfentanil hydrochloride injection by ICP-MS*
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Zi-zhen GAO, Lei LI, Ru-ling XU, Xiang-yang XU**
Chinese Journal of Pharmaceutical Analysis | 2024, 44(2) : 280 - 289
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(2): 280-289
• Safety Monitoring •
Determination of 25 elements impurities in alfentanil hydrochloride injection by ICP-MS*
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Zi-zhen GAO, Lei LI, Ru-ling XU, Xiang-yang XU**
Affiliations
  • Jiangsu Nhua Pharmaceutical R&D Co, Ltd, Xuzhou, Xuzhou Jiangsu 221100
Published: 2024-02-29 doi: 10.16155/j.0254-1793.2024.02.11
Outline
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Objective:

To establish an inductively coupled plasma mass spectrometry (ICP-MS) method for the determination of 25 potentially risky elemental impurities in alfentanil hydrochloride injection.

Methods:

The Agilent 7800 ICP-MS inductively coupled plasma mass spectrometer was used, the conventional tuning mode was used, the RF power was 1 550 W, the plasma gas flow rate was 15 L·min-1, the matrix effect was eliminated by external standard, and the sample was diluted for direct injection.

Results:

The method can simultaneously determine the content of 25 kinds of elemental impurities, and its linear relationship was good (r >0.99). The RSD of the repeatability test was ≤10% (n=6), and the recovery rate was 80.0%-120.0% (n=9), all of which met the requirements of methodological validation.

Conclusion:

The content of elemental impurities in alfentanil hydrochloride injection is lower than 30% of the limit specified in ICH·Q3D, which will not bring safety risks to the drug, providing a reference for the quality control and risk assessment of elemental impurities in other similar drugs.

alfentanil hydrochloride injection  /  inductively coupled plasma mass spectrometry  /  element impurities  /  methodology validation  /  content determination  /  impurity limit
Zi-zhen GAO, Lei LI, Ru-ling XU, Xiang-yang XU. Determination of 25 elements impurities in alfentanil hydrochloride injection by ICP-MS*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (2) : 280 -289 . DOI: 10.16155/j.0254-1793.2024.02.11
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Year 2024 volume 44 Issue 2
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Article Info
doi: 10.16155/j.0254-1793.2024.02.11
  • Online Date：2026-03-13
  • Published：2024-02-29
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History
  • Revised：2023-11-20
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    Jiangsu Nhua Pharmaceutical R&D Co, Ltd, Xuzhou, Xuzhou Jiangsu 221100
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栓菌属 Trametes 5 2.39
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