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Pharmaceutical Manufacturing and Packing Sourcer

Streamlining Standardisation in E&L

PMPS: What are the biggest dangers to consumers from E&Ls?

David Weil: Addressing how leachables from packaging, storage containers, and single-use-system manufacturing could adversely affect final drug products’ stability and efficacy is vital to ensuring consumer safety. Analysis is done of the chemical composition and concentration levels uncovered regarding any impurities found that could potentially impact consumers. An example could be leachables from rubber stoppers in syringes, or compound migration from secondary/tertiary packaging affected products, both of which could pose a danger to consumers and also result in a product recall.

What methods are most effective at analysing E&Ls in pharmaceuticals?

A combination of high-resolution gas chromatography-tandem mass spectrometry (GC-MS/MS) (for volatile compounds), and high-resolution liquid chromatography-tandem mass spectrometry (LC-MS/MS) (semi-volatile/non-volatile compounds) analytical methods, in combination with alternative detection methods such as flame ionisation detector for GC-MS and ultraviolet/charged aerosol detection/evaporative light scattering detector (UV/CAD/ELSD) are the most effective methods for the analysis of E&L compounds in pharmaceuticals. These high-resolution methods provide the accurate mass and MS-MS information required for more confident compound identification above the analytical evaluation threshold (AET) level.

How is it ensured that toxic impurities are removed from any one sample or medicine?

There are several considerations that manufacturers should weigh. These should include the screening of raw materials, the performance of a risk assessment of the manufacturing process, a thorough review of the raw materials used in the manufacturing and packaging, and following the industry-standard protocols for E&L analysis.

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David Weil is a Senior Applications Scientist/Extractable Leachable Analysis Expert at Agilent Technologies. His areas of expertise include metabolomics, pharmaceutical, and environmental analysis using liquid chromatography/mass spectrometry (LC/MS). David is particularly skilled in high-resolution mass spectrometry, with an emphasis on metabolomics and impurity profiling working with ultra-high resolution and sensitive LCMS systems. Prior to Agilent, David worked for many years at 3M as a Senior Research Scientist. David holds a Bachelor of Science in Chemistry from Drake University, Iowa, US, and a PhD in Physical Chemistry from the University of Minnesota, US.
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Stevanato Group signs an agreement with Nelson Labs to provide best-in-class Extractables and Leachables testing services at its US Technology Excellence Center

Piombino Dese, Padua Italy and Salt Lake City, USA September 2, 2020: Italian-based Stevanato Group, a leading producer of glass primary packaging and provider of integrated services for combination products, and Nelson Laboratories, LLC, a global provider of lab testing and expert advisory services signed today a partnership agreement that will provide Extractables and Leachables testing at SG US Technology Excellence Center in Boston, MA.
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