Details

Autor(en) / Beteiligte

• Torres, Susana
• Boetzel, Ruth
• Gatimu, Enid
• Gomes, Diego Zulkiewicz
• King, Fiona
• Kocks, Grace
• Jones, Richard
• Day, Christopher
• Lewen, Nancy
• Harris, Laurence
• Teasdale, Andrew

Titel

ICH Q3D Drug Product Elemental Risk Assessment: The Use of An Elemental Impurities Excipients Database

Ist Teil von

• Journal of pharmaceutical sciences, 2022-05, Vol.111 (5), p.1421-1428

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2022

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.