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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:
| Analytical Workflows for E&L analysis | |||
|---|---|---|---|
| Elemental Impurities | Volatile organic impurities | Semi-volatile organic impurities | Non-volatile organic impurities |
Featured extractables and leachables categories
Accelerated extraction for fast material selection studies
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.
Featured videos
Extractables and Leachables: Challenges and SolutionsE&L challenges & Thermo Scientifics differentiated solutions to increase sample throughput, streamline workflows, and increase confidence in results.
Extractables & Leachables: OverviewE&L analysis overview of differentiated solutions to increase sample throughput, streamline workflows, and increase confidence in results.
Extractable & Leachable CRO ASE 350 TestimonialGlobal pharmaceutical CRO chooses Thermo Scientific Dionex ASE 350 Accelerated Solvent Extractor for automated, compliant sample preparation for the study of extractable impurities from drug packaging and production systems
Global pharmaceutical CRO chooses Thermo Scientific Q Exactive Plus and Compund Discover for identification of Extractable & Leachable impuritiesA range of impurities are made together with any medicine. Learn how and why a global CRO chose Thermo Scientific's Q Exactive Plus and Compound Discover to identify and profile extractable and leachable impurities.
Global pharmaceutical CRO chooses iCAP RQ & Qtegra ISDS software for identification and quantification of elemental Extractable & Leachable impuritiesElemental analysis and trace metals testing are important for the commercial release of pharmaceutical products, stability studies, extractable and leachable studies, and clinical trial support.
Exactive GC Testimonial Video with Leading GMP Testing Service ProviderAn anonymized video showcasing Thermo Fisher's Exactive GC instruments conducting impurity analysis.
Comprehensive Extractables Analysis of Medical Grade O-RingKeeley Murphy describes a comprehensive extractables analysis of USP class VI O-rings using the Q Exactive Plus MS, iCAP Q ICP-MS for trace element analysis, and the software packages SIEVE, Mass Frontier, and mzCloud spectral databases.
No More Unknowns – Workflows for Extractable and Leachable ImpuritiesKyle D'Silva, Pharma & Biopharma Vertical Marketing Manger, gives a preview of his AAPS 2015 seminar, No More Unknowns - A Complete Analytical Workflow for Extractable and Leachable Impurities.
AAPS 2015 - Extractable and Leachable Impurity AnalysisKyle D'Silva's AAPS presentation that covered impurity analysis (extractables and leachables).
No More Unknowns – Analytical Workflow for Extractable and Leachable ImpuritiesHear about the latest workflows for analysis of elemental and organic leachable container-closure system pharmaceutical impurities.
Solving the Challenges of Leachable Pharmaceutical Impurities Using a Full Analytical PortfolioExtractables and leachable compounds are a complex and ever growing list of pharmaceutical impurities. Stephen Guilfoyle discusses developments in the regulatory landscape and a broad portfolio of tools to meet these challenges.
Talking Extractables and Leachables – Glaxo Smith KlineJason Creasey (Glaxo Smith Kline) discusses the history of extractable and leachable testing and how the industry has evolved due to growing knowledge of contact-closure materials provided as new analytical tools became available.
Talking Extractables and Leachables – No More Unknowns?Kyle D’Silva discusses new developments in GC-MS technology for Extractables and Leachables testing, including the new Q Exactive™ GC hybrid quadrupole-Orbitrap GC-MS/MS and mzCloud.org online mass spectral library.
Talking Extractables and Leachables – Smithers RapraAndrew Feilden (Smithers Rapra) discusses how the E&L Conference is advancing the knowledge of container closure systems for the pharmaceutical industry.
Talking Extractables and Leachables – Testing Using Orbitrap-based Mass SpectrometryKate Comstock discusses her long experience with extractables testing in pharmaceutical companies, and how the discipline has evolved through the latest technological developments in mass spectrometry.
Extractable & Leachable Compounds: Combining Targeted & Non-targeted Screening to Improve Unique IdentificationsRecent webinar discussing the screening of targeted and non-targeted E&L compounds
Testing for extractables & leachables in pharmaceutical contact closure materials - A Complete ICP-MS, GC-MS & LC-MS WorkflowGet insight into extractable/leachable study designs following regulatory guidelines for both elemental and organic impurities.
Understanding the Challenges of E&L Contaminant Analysis for Pharmaceutical Quality AssuranceRecent webinar discussing the basics of Extractables and Leachables with respect to Pharmaceutical QA.
Using GC & LC Orbitrap mass spectrometry to confidently identify leached packaging and process impuritiesLearn the latest instrument technology for unknown impurity identification and follow a leachable study for both GC and LC amenable organic impurities.
Enhance your capabilities
Unknown impurity identification and quantification workflows for:
- Pharmaceutical packaging and contact-closure materials
- Medical devices
- Food contact materials
