Extractables and Leachables Testing
Products & Services
Information
Our scientists conduct E&L analysis studies in accordance with regional guidance and nationally and internationally recognized standards, including Good Manufacturing Practice (GMP), Product Quality Research Institute (PQRI) extractables and leachables guidelines, United States Pharmacopeia (USP) requirements (e.g., USP chapters <665>, <1665>, <1663>, <1664>, and <1664.1>), Korean Pharmacopeia requirements, European Medicines Agency (EMA) guidance, US Food and Drug Administration (FDA) guidance, BioPhorum/BPOG guidance, and ISO 10993-18 extractables and leachables guidelines (Part 18). We also provide testing of glass packaging according to USP<1660> Glass Delamination Studies.
As an initial step, we aim to gather all information about your packaging system in order to build a robust picture of potential sources of leachables. The combination of our experience in method development for a controlled extractables study, coupled with our vast knowledge of leachable compounds and guidelines, means that we can anticipate and identify potential sources of risk associated with leachable impurities through strategic screening studies.
Our analytical teams can determine both organic and inorganic contaminants through the application of a range of advanced analytical instrumentation including liquid chromatography with HRAM-mass spectrometry detection (LC-MS/MS), gas chromatography with enhanced resolution or HRAM-mass spectrometry (GC-MS/MS), and inductively coupled plasma spectroscopy (ICP-OES or ICP-MS). In addition to the solvent-based extractions, we also apply various high performance automated solventless extraction methods, such as solid-phase microextraction (SPME), dynamic head-space and thermal desorption for better characterisation and understanding of materials.
Typical study types include extractables assessment of container closure systems and packaging components.
https://www.intertek.com/pharmaceutical/analysis/extractables-leachables/
