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

To support the practical implementation of the International Council for Harmonisation (ICH) Q3D guideline, which describes a risk-based approach to the control of elemental impurities in drug products, a consortium of pharmaceutical companies has established a database to collate the results of ana...

Full description

Saved in:
Bibliographic Details
Published in:Journal of pharmaceutical sciences 2018-09, Vol.107 (9), p.2335-2340
Main Authors: Boetzel, Ruth, Ceszlak, Agnieszka, Day, Christopher, Drumm, Patrick, Gil Bejar, Joan, Glennon, John, Harris, Laurence, Heghes, Crina I., Horga, Radu, Jacobs, Peter L., Keurentjes, Wilfried J.T.M., King, Fiona, Lee, Carlos W., Lewen, Nancy, Marchant, Carol A., Maris, Frans A., Nye, William, Powell, Samuel, Rockstroh, Helmut, Rutter, Laura, Schweitzer, Mark, Shannon, Elaine, Smallshaw, Lance, Teasdale, Andrew, Thompson, Sarah, Wilkinson, David
Format: Article
Language:English
Subjects:
analytical chemistry
excipients
formulation
mass spectrometry
regulatory science
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:To support the practical implementation of the International Council for Harmonisation (ICH) Q3D guideline, which describes a risk-based approach to the control of elemental impurities in drug products, a consortium of pharmaceutical companies 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 results of 26,723 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 coverage of 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 studies for 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 organizations and 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 in formulated 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.
ISSN:0022-3549
1520-6017
DOI:10.1016/j.xphs.2018.04.009