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Comprehensive Extractables and Leachables Analysis for Drug Development
Find out how the Extractables and Leachables Service at LGC can help identify and solve problems with drug packaging and delivery
8 Feb 2017
Lucy Vass
Administrator / Office Personnel
Editorial article
Stephen Feely, Client Manager at the CMC Department within Drug Development Services at LGC
We’re developing our screening methods to help provide our clients with more comprehensive data to allow them to make more informed judgements
Stephen Feely,Drug Development Services, LGC
Stephen Feely, a Client Manager of the CMC Department within Drug Development Services at LGC, explained how the extractables and leachables service can help clients identify and quantify compounds within their drug product which are derived from the packaging or delivery system.
The department has the capability to analyze inorganic and organic compounds using a range of methods such as ICP-MS, and GC-MS and LC-MS.
“The reports we deliver to our sponsors include the extractables and leachables data as well as guidance on what next steps to take” he says. Stephen highlights that the department works with the client to identify what methods need to be developed to assess and solve potential problems within their drug product.
Watch the full interview here and visit and visit LGC’s company profile to find out more about its services.
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LC-MSLC-MS (liquid chromatography-mass spectrometry) systems and equipment are used for separation and quantitative analysis of complex mixtures, combining liquid chromatography and mass spectrometry. Quantify proteins, contaminants, pesticides or screen for drug metabolites with a high level of sensitivity. LC-MS systems and equipment include reverse phase, normal phase and specialized columns integrated with various MS detectors such as time-of-flight (TOF), quadrupole, orbitrap or ion trap mass analyzers. LC-MS/MS instruments equipped with a qTOF or triple quadrupole analyzer give greater sensitivity and resolving power to your analysis. Find the best LC-MS equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Mass SpectrometryMass spectrometry (MS) is a powerful analytical technique used to identify and quantify molecules based on the mass-to-charge ratio of gas-phase ions. It provides detailed information about the structure, composition, and properties of compounds and is widely used across fields such as environmental monitoring, materials science, drug discovery and development, food and beverage testing, and wider chemical research. Key MS techniques include tandem mass spectrometry (MS/MS), liquid chromatography–mass spectrometry (LS-MS) and inductively coupled plasma (ICP-MS). Choosing from these wide range of techniques and technologies can be a daunting task, so keep up to date with scientific applications, performance expectations, and customer reviews here all in one place. Visit our product directory to receive quotes direct from the manufacturer.
GC-MS GC-MS (gas chromatography-mass spectrometry) instruments and equipment are used to separate, quantify and identify mixtures of small and volatile compounds, such as polycyclic aromatics, fatty acids and alcohols. Often used in drug detection, forensic investigation and environmental analysis for pesticides and contaminants, GC-MS is a powerful addition to your lab’s analytical capabilities. GC-MS/MS instruments equipped with a qTOF or triple quadrupole analyzers can give greater sensitivity and resolution to your analysis. Find the best GC-MS instruments and equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. Shipping / PackagingPackaging is the technology of enclosing or protecting products for distribution, storage, sale, and use and the process and production of packages. Packaging is closely linked to Shipping and the preparing of goods for transport, warehousing, logistics, sale, and end use. Within the pharmaceutical industry packaging and shipping are used for transport, storage and logistics between Contract Research Organizations (CROs), Manufacturing and Clinical Trial companies. Packaging is also critical in the final production of a pharmaceutical product before market. RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Compound IdentificationOrganic CompoundsOrganic compounds are carbon-based molecules that form the building blocks of life. These include hydrocarbons, lipids, proteins, and nucleic acids. Understanding organic compounds is crucial in chemistry, biochemistry, and pharmacology. Explore organic compound analysis tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.ToxicityToxicity is defined as the degree to which a substance can harm humans or animals. It is essential to study the toxicity of pharmaceutical products during the development process so that optimum dosage can be established for the administration of the drug.Drug DevelopmentDrug development refers to the process of bringing a new drug to market.