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Validation of Quantitative Method for Determination of Elemental Impurities in Pharmaceutical Products Following USP 232/233 on ICPMS-2030

17 minutes

24 targeted elemental impurities in three drug products were determined following new USP chapters <232>/<233> using Shimadzu ICPMS-2030. The method was evaluated and validated according to the procedures defined by USP <233> and combined with microwave digestion for sample preparation. Good calibration linearity, repeatability, stability and specificity were achieved for all 24 impurities. Low LODs and LOQs were obtained as compared to the target limits from USP <232>. The ICP-MS method applying universal He collision mode provides a high throughput method for routine elemental impurity analysis in pharmaceutical products.

Learning Objectives:

  • Background and introduction to the new USP chapters <232>/<233> 
  • Understand the ICP-MS method for elemental impurity analysis in drugs
  • Explore the method evaluation and validation conducted



Raymond Li (Ph.D)
Senior Application Chemist
Shimadzu (Asia Pacific)

Dr. Raymond joined Centre of Application Solutions, SAP since 2017. He obtained his B.S. from Nankai University in Material Chemistry in 2003 and Ph.D. from University of Singapore in 2008. He has been a research fellow at Agency for Science, Technology and Research (A*STAR), Singapore. Before joining Shimadzu, he has 7 years’ experience in the R&D department at PerkinElmer. His expertise lies in elemental analysis in various applications and specializes in ICP and ICPMS.





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