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ICH Q3D Drug Product Elemental Risk Assessment: The use of an elemental impurities excipients database

Torres S; Boetzel R; Gatimu E; Gomes D; King F; Kocks G; Jones R; Day C; Lewen N; Harris L; Teasdale A;

The purpose of this publication is to show how an elemental impurities excipient database can be used in assisting the execution of a drug product elemental impurities risk assessment as required by the ICH Q3D guidelines.

As a result of this exercise, we have demonstrated that the database, used in conjugation with other sources of information, is a credible source of elemental impurity levels in excipients therefore, a valuable source of information in completion of drug product risk assessments. This useful collection of data helps to reduce the burden of analytical testing for elemental impurities in excipients.


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