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Elemental Impurities FAQs

This FAQs section details frequently asked questions about the Elemental Impurities database.
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Is this database accepted by a European Authority of pharmaceutical products?

Records in the database can be considered to have equivalent provenance to information found in the published literature. ICH Q3D Section 5 lists published literature as a source of information to be used in risk assessment. It is the Consortium intent to further engage with European regulators to increase awareness and acceptability.

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