Elemental impurities – A database to facilitate the risk assessment of active ingredients and excipients

One of the main demands of the Guideline ICH Q3D is to carry out risk assessments on metallic impurities. A database with analytical data provides a valuable support. Learn more about the data sharing using the new elemental impurities database.

http://www.gmp-compliance.org/enews_04843_Elemental-impurities—A-database-to-facilitate-the-risk-assessment-of-active-ingredients-and-excipients_9263,9300,S-QSB_n.html

Released in December 2014, the ICH Q3D Guideline on Elemental Impurities contains extensive specifications for the control of a total of 24 elements (21 metals, 3 metalloids) that can be present as impurities in pharmaceutical products. Main sources can be

• Active ingredients
• Excipients (including water)
• Processing auxiliaries and catalysts
• Production equipment
• Container and closure systems

The Guideline ICH Q3D calls for a risk assessment with regard to the presence of metallic impurities in various dosage forms, taking into account the respective limit values. The main factors of influence are to be included (see fishbone diagram on p. 6 of the Guideline). The risks identified in a comprehensive analysis…