Whitepaper: The use and utility of General Chemistry Data in extractables assessment

The purpose of this Technical Communication is to establish how General Chemistry Data obtained in controlled extraction studies, such as pH, UV absorbance and total organic carbon (TOC), is reported, used and discussed as part of a rigorous extractables assessment.

Extracts and extraction blanks are screened and/or profiled by relevant and appropriate analytical methods to establish the identity and concentration of all extracted substances at levels higher than an established threshold. This is the case as extractables’ identities and concentrations are essential information required to assess the effect of extracted substances (should they become leachables) on certain critical drug product quality attributes including safety, efficacy, stability and compliance.