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:
| Analytical Workflows for E&L analysis | |||
|---|---|---|---|
| Elemental Impurities | Volatile organic impurities | Semi-volatile organic impurities | Non-volatile organic impurities |
Featured extractables and leachables categories
Automate extraction, in-cell cleanup and evaporation of compounds from solid and semi-solid samples using the Thermo Scientific EXTREVA ASE Accelerated Solvent Extractor. The EXTREVA ASE system can perform four parallel sample extractions, substantially increasing throughput and efficiency. Because the entire sample preparation workflow is automated in one seamless operation, no manual transfer of samples between steps is required. Get reproducible and efficient parallel extractions that cut manual sample preparation steps from hours to minutes, increase productivity, minimize errors, and dramatically reduce solvent use to meet laboratory sustainability and cost goals.
The Thermo Scientific Orbitrap IQ-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 contact-closure materials
- Medical devices
- Food contact materials
