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Elemental Impurities FAQs

This FAQs section details frequently asked questions about the Elemental Impurities database.
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If we are doing risk assessment on final drug product, is it required to obtain elemental impurities data on API and excipient?

Final drug testing alone is likely not sufficient for risk assessment purposes. Additional testing of API and excipients may not be necessary if scientific arguments or supporting data from other sources are sufficient to satisfy the regulator that the risk is sufficiently low to negate the need. The elemental impurities database has been used by our members to support their Q3D risk assessments.

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