IPEC e-newsletter - Excipients Insight September 2016 - 30-09-16


Inside this issue


PQRI-backed study looks for snapshot of elemental impurities analysis

The US Product Quality Research Institute (PQRI) is looking for labs to participate in a study to assess variability in the analysis of pharmaceutical products for elemental impurities (EI).

This inter-laboratory study will provide a comparison of methods in support of updated EI guidelines for finished pharmaceutical products (i.e. ICH Q3D and USP Chapters <232> and <233>. It will focus on instrumental parameters and extraction techniques, and is designed to provide a snapshot of the state of the industry in preparation for EI guideline implementation.

The primary objectives of the study are to:

  • assess inter-laboratory accuracy and precision for standardised pharmaceutical-related samples; assess effectiveness of microwave digestion;
  • compare acid leaching extraction techniques to total metal extraction;
  • examine the correlation between the analysis and summation of individual components to a formulated mixture; and
  • compare ICP-MS and alternative techniques (ICP-OES and XRF).

Each participating laboratory will receive 1-3 powder or tablet evaluation samples for extraction and analysis and a solution sample for analysis only. 

Should you wish to participate, please inform the IPEC Europe Secretariat as soon as possible. The final ICH Q3D modules can be downloaded from the ICH Q3D website.




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