An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment
25. April 2018
To support the practical implementation of the ICH Q3D guideline, which describes a risk-based approach to the control of elemental impurities in drug products, a consortium of pharmaceuticalcompanies has established a database to collate the results of analytical studies of the levels of elemental impurities within pharmaceutical excipients. This database currently includes the resultsof 26723 elemental determinations for 201 excipients and represents the largest known, and still rapidly expanding, collection of data of this type. Analysis of the database indicates good coverageof excipients relevant to real-world drug product formulations and tested element profiles consistent with ICH Q3D recommendations. The database includes the results from multiple analytical studiesfor an excipient and thus incorporates within it an indication of both excipient supplier and batch-to-batch variability as well as any variability associated with the different testing organisationsand methods employed. The data confirm the findings of earlier smaller studies that elemental impurity concentrations in excipients are generally low and when used in typical proportions informulated drug products are unlikely to pose a significant patient safety risk. The database is now in active use as one line of evidence in ICH Q3D risk assessments.