Sources, Effects, And The Importance Of Elemental Impurities For Finished Drug Products

Source: Catalent

Elemental impurities can arise from a variety of sources, such as active pharmaceutical ingredients (API), excipients, manufacturing equipment, and primary container closure systems.  ICH Q3D recommends that manufacturers conduct a product risk assessment by identifying and assessing known and potential sources of elemental impurities.  This webinar reviews the impact of the most recent regulatory changes related to elemental impurities testing, guidance on the best routes to compliance, and an overview of the elemental impurities risk assessment process.


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