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Elemental Impurities FAQs

This FAQs section details frequently asked questions about the Elemental Impurities database.
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What is the risk that only excipients with low levels of elemental impurities data are submitted to the Lhasa database?

Currently, the data in the database represent the major excipients used by 14 pharmaceutical companies in their product development. There is no advantage to either pharmaceutical or excipient supplier data donors in submitting biased data to the database (in the latter case particularly since the supplier name is blinded) and the risk of this type of bias is therefore considered to be low. Active management from the consortium ensures data is available on common excipients. The FDA novel drug approval lists are reviewed annually to ensure that excipients being used in the pharmaceutical industry are covered in the database. A list of prioritised excipients is maintained so selective testing can be completed by members to fill recognised knowledge gaps.

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