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Extractables and Leachables for QC Laboratories

Extractables and Leachables for QC Laboratories

Manufacturers of pharmaceuticals, drug packaging components, medical devices, and packaged food products have come under growing pressure to perform sensitive and accurate analytical studies to detect, identify, and quantify extractable and leachable compounds (E&Ls). E&Ls may potentially be toxic or have otherwise undesirable effects on the efficacy of drugs. Regulatory guidance related to the application, performance, and reporting of E&L studies is increasing and examples and data are accumulating. E&L analysis is still an evolving area of investigation.
At Agilent, we partner with you to enable confident identification and quantification of potential E&Ls in extracts that are derived from contact closure system components and packaging materials. We also provide software tools for E&L analysis, library spectral comparison, de novo structure identification, and differential sample analysis.
For Research Use Only. Not for use in diagnostic procedures.

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