Extractables and Leachables
Advanced techniques for extractables testing
Extractable and leachable (E&L) testing methods, such as draft pharmacopeial chapters USP 1663 and USP 1664, demand carefully controlled extraction. Traditionally, routine extractables testing has been performed using soxhlet and reflux extraction, which have lengthy extraction times (over 24 hours), variability in manual handling, and require disposal of potentially flammable and hazardous organic solvents.
Accelerated solvent extraction is a proven technology with significant improvements over traditional extraction techniques. You can use less bench space, extract up to 10 times faster, and use less solvent.
Extractables extraction workflow
Once extracted the samples follow one of four analytical workflows:
Featured extractables and leachables categories
Automate extraction, filtration, and clean-up of compounds from solid and semisolid samples in minutes using the automated Thermo Scientific™ Dionex™ ASE™ 350 Accelerated Solvent Extractor. This system accommodates sample sizes of 1-100g, allows unattended extraction of up to 24 samples, and uses 50-90% less solvent compared to other methods. The chemically inert pathway supports acid and alkaline sample matrices and solvents. Flexible, easy-to-operate, cost-effective, and operated under compliant software, the Dionex ASE 350 is ideally suited for high-throughput, GxP laboratories.
The Thermo Scientific Orbitrap ID-X Tribrid Mass Spectrometer combines industry-leading mass analyzer technology dedicated for small molecule analysis with the Thermo Scientific AcquireX intelligent MSn data acquisition strategy, to collect more meaningful data.
Unknown impurity identification and quantification workflows for:
- Pharmaceutical, packaging, and container-closure material extractable and leachable studies
- Food contact materials (FCM) testing
- Non-intentionally added substances (NIAS) testing