The Elemental Impurities Data Sharing Consortium was established in 2016 to share analytical data on the levels of trace elements found in common excipients used in the formulation of pharmaceutical drug products. This is used to assess risks under ICH Q3D by both industry and regulators.
Joining this data sharing initiative gives organisations access to a high-quality dataset on excipient elemental impurity levels, that is not currently available in the public domain. This pre-competitive collaboration provides a forum for members to work together to share best practice and address common issues.
The Elemental Impurities Database is the largest known collection of this type of data and currently contains:
- 41,273 elemental determinations
- 3,050 analytical studies
- This data covers 300 excipients
Our latest publication, ‘ICH Q3D Drug Product Elemental Risk Assessment: The Use of An Elemental Impurities Excipients Database’, describes how the database supports scientifically driven risk assessments under ICH Q3D.
Please contact us for more information on how you can access this valuable resource.