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Extractables and Leachables Workflow – Identify all Suspects

Extractables and Leachables Workflow – Identify all Suspects
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Extractables and Leachables Workflow – Identify all Suspects - 1

Thermo Scientific Extractables & Leachables Workflow all suspects Unknown impurity identification and quantification workflows for: • Pharmaceutical, packaging and contact-closure materials • Food contact materials • Non-intentionally added substan

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Extractables and Leachables Workflow – Identify all Suspects - 2

Food contact materials A Food Contact Material (FCM) is any material approved for food use, which comes in contact with food or drink products during manufacturing, packaging, preparation and storage. • A FCM must not transfer chemicals to, or cause changes to, foods that may impact consumer health. • Testing is driven by regulation and demands migration studies that assess all ‘unknown’ non-intentionally added substances. Factors Affecting Migration Higher temperatures increase leaching. Long storage time increases leaching. FOOD TYPE PACKAGING SIZE Fatty/acidic foods & liquids have...

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Extractables and Leachables Workflow – Identify all Suspects - 3

Pharmaceutical contact-closure materials Extractable and Leachable compounds can migrate from polymeric materials used in container closure, production, delivery and packaging systems for pharmaceuticals and biopharmaceuticals. • Extractables migrate from container materials when exposed under laboratory conditions to solvents under exaggerated temperature and time environments. • Leachables are chemical species that migrate into the product under normal storage or use conditions. Ink Solvent Adhesive Varnish Plasticizer Lubricant Pigment Stabilizer Antioxidant Monomer Slip agent Flame...

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Extractables and Leachables Workflow – Identify all Suspects - 4

Low molecular weight, non-polar organic compounds are typically volatile and have the highest probability to migrate from or through polymeric contact closure systems. Testing of the contact closure material is typically conducted by headspace sampling followed by gas chromatography and mass spectrometry. Moleclar Weight Volatiles HPLC NO MORE VOLATILE UNKNOWNS IN MANY EXTRACTABLES AND LEACHABLES LABORATORIES, SAMPLE PREPARATION OFTEN ACCOUNTS FOR MORE THAN TWICE THE TIME SPENT ON ACTUAL CHROMATOGRAPHY. IMPROVED SAMPLE HANDLING CAN REDUCE TURNAROUND TIMES AND SIGNIFICANTLY LOWER THE COST...

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Extractables and Leachables Workflow – Identify all Suspects - 5

Qualitative and quantitative GC-MS with full 21 CFR 11 compliance. Simple to operate and fully compliant Thermo Scientific™ Dionex™ Chromeleon™ Chromatography Data System (CDS) software provides mass spectrometry data acquisition and processing for GxP environments.

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Extractables and Leachables Workflow – Identify all Suspects - 6

Semi-volatiles Semi-volatile compounds are among the most frequently detected migration impurities. Testing is performed through liquid injection of an extract of the material or product. Often extracts are derivatized to increase analyte volatility. Testing demands absolute confidence in unknown identification and quantification. CONFIDENT IDENTIFICATION DEMAND THE ‘QUANFIRMATION’ POWER OF ORBITRAP HIGH-RESOLUTION, ACCURATE-MASS (HRAM) MASS SPECTROMETRY. RESOLVE INTERFERENCES FOR THE CLEANEST SPECTRA; ACHIEVE EXCEPTIONAL MASS ACCURACY FOR CONFIDENT IDENTIFICATION OF UNKNOWNS; ELEMENTAL...

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Extractables and Leachables Workflow – Identify all Suspects - 7

Exceptional <1ppm mass accuracy is achieve on every scan, on every mass, and at every concentration. ORBITRAP COMES TO GC-MS The Thermo Scientific™ Q Exactive™ GC Orbitrap™ GC-MS/MS system provides comprehensive characterization of samples in a single analysis for the highest confidence in compound discovery, identification, and quantitation. This system offers the quantitative power of a GC triple quadrupole MS combined with the high precision, full scan HR/AM capabilities only available in combination with Thermo Scientific™ Orbitrap™ technology. Perform targeted screening, routine...

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Extractables and Leachables Workflow – Identify all Suspects - 8

Non-volatiles Non-volatile impurities are among the most difficult to identify. Ever-changing polymer additives and monomers represent an ongoing analytical challenge. Confident identification using a range of targeted libraries or advance high resolution accurate mass (HRAM) cloud based spectral libraries simplify the workflow. PROVEN PERFORMANCE FOR EXTRACTABLES IDENTIFY AND CONFIRM MORE COMPOUNDS RAPIDLY AND WITH CONFIDENCE USING THE THERMO SCIENTIFIC™ Q EXACTIVE™ HYBRID QUADRUPOLE-ORBITRAP MASS SPECTROMETER AND ELEMENTAL IMPURITIES THERMO SCIENTIFIC™ VANQUISH™ UHPLC. Robust...

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Extractables and Leachables Workflow – Identify all Suspects - 9

Search spectra on-line with mzCloud,™ a free to search online HRAM mass spectral library. Full spectral annotation with MSn data, spectral trees and substructure search capabilities. THIS BENCHTOP LC-MS/MS SYSTEM COMBINES INDUSTRY LEADING CHROMATOGRAPHY WITH QUADRUPLE PRECURSOR ION SELECTION AND HIGH-RESOLUTION, ACCURATE-MASS (HRAM) ORBITRAP DETECTION TO DELIVER EXCEPTIONAL PERFORMANCE AND VERSATILITY. Thermo Scientific™ Compound Discoverer™ software ensures confident compound identification and structural elucidation with advanced algorithms that quickly process and identify changes...

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Extractables and Leachables Workflow – Identify all Suspects - 10

Elemental impurities Elemental impurities are common in printed materials, pigments, foil based packaging and delivery systems. Elemental impurities are analyzed following ICH Q3D or USP 232 and 233 guidelines. Robust, compliant analysis at the lowest levels is provided by ICP-MS or ICP-OES. Your time is precious. Spend less time at the instrument by using automated, unattended system set-up routines like the advanced single-click ‘Get Ready’ function in Thermo Scientific™ Qtegra™ Intelligent Scientific Data Solution™ (ISDS) software. ELEMENTAL IMPURITIES AUTOMATE MORE Automation of the lab...

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Extractables and Leachables Workflow – Identify all Suspects - 11

SIMPLICITY, PRODUCTIVITY, ROBUSTNESS GAIN COMPLETE CONFIDENCE WITH ACCURATE RESULTS. ENJOY MINIMAL MAINTENANCE THANKS TO OUR INTELLIGENTLY ENGINEERED DESIGN. THE THERMO SCIENTIFIC™ iCAP™ RQ ICP-MS HAS THE ANALYTICAL PERFORMANCE TO COMFORTABLY MEET THE MOST CHALLENGING PHARMACEUTICAL REGULATORY REQUIREMENTS FOR ELEMENTAL IMPURITIES, INCLUDING LIMITS FROM THE INTERNATIONAL COUNCIL ON HARMONIZATION (ICH) GUIDELINE Q3D AND THE U.S. PHARMACOPEIAL CONVENTION (USP) CHAPTERS 232, 233 & 2232. Designed to comply with the most rigorous data audit and security measures, Qtegra ISDS software is FDA 21...

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