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An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment.

Ruth Boetzel1, Agnieszka Ceszlak2, Christopher Day3

  • 1Pfizer Inc., Sandwich CT13 9NJ, UK.

Journal of Pharmaceutical Sciences
|April 22, 2018
PubMed
Summary

A large pharmaceutical excipient database supports the International Council for Harmonisation (ICH) Q3D guideline for elemental impurities. Data show low impurity levels, indicating minimal patient safety risks in drug products.

Keywords:
analytical chemistryexcipientsformulationmass spectrometryregulatory science

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Regulatory Science

Background:

  • The International Council for Harmonisation (ICH) Q3D guideline mandates a risk-based approach for controlling elemental impurities in drug products.
  • Pharmaceutical excipients are critical components in drug formulations and require thorough elemental impurity analysis.
  • Variability in elemental impurity levels can arise from excipient suppliers, manufacturing processes, and analytical methodologies.

Purpose of the Study:

  • To establish a comprehensive database of elemental impurity levels in pharmaceutical excipients.
  • To support the practical implementation of the ICH Q3D guideline for risk assessment.
  • To provide a robust dataset for evaluating elemental impurity profiles in excipients.

Main Methods:

  • A consortium of pharmaceutical companies collated analytical study results for elemental impurities in excipients.
  • A database was created containing 26,723 elemental determinations for 201 different excipients.
  • Data analysis focused on excipient coverage, element profiles, and variability indicators.

Main Results:

  • The database represents the largest known collection of elemental impurity data for pharmaceutical excipients.
  • Excipients included in the database show good coverage for real-world drug product formulations.
  • Elemental impurity concentrations in excipients are generally low, consistent with ICH Q3D recommendations.

Conclusions:

  • The collated data confirm that elemental impurities in excipients are typically at low levels.
  • The use of these excipients in drug products is unlikely to pose a significant patient safety risk.
  • The database is actively utilized as evidence in ICH Q3D risk assessments.