Extractables/Leachables

Maxxam has accumulated expertise in designing studies and developing methods to measure extractables in short term stress tests and leachables in long term stability studies. The FDA Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics, defines many of the requirements for determining the suitability of a container closure system including the need to demonstrate the absence of extractables/leachables or to show that their levels are below the recognized safety guidelines.

Maxxam has developed procedures for characterizing and quantifying the presence of leachable additives, such as calcium or zinc stearate and phthalates from plastic products in a variety of matrices. These matrices may include:

  • Plasticizers (Phthalates)
  • Mold Release Agents (stearates)
  • Heavy Metals (Zn, Pb, Hg)
  • Inks & Dyes

To assist in identifying unwanted extractable components in leachates of plastic materials, a NIST traceable library is employed to simplify complex GC-MS spectra. While this technique is best-suited for the determination of volatile species, LC-MS can be used to analyze these leachates and characterize the non-volatile extractable components. For elemental impurities / additives and characterization of plastic materials, the laboratory uses high-pressure microwave digestion, followed by conventional ICPMS analyses.

Maxxam has accumulated expertise in designing studies and developing methods to measure extractables in short term stress tests or leachables in long term stability studies. Studies rely on a diverse suite of analytical instrumentation including: ICPMS, LC-ICPMS, IC, HPLC, LC/MS and GC/MS.

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Donna Garbutt, M.B.A. Chief Executive Officer Maxxam is the Canadian market leader in analytical services and solutions to the energy, environmental, food and DNA industries and a member of the Bureau Veritas Group of companies – a world leader in testing, inspection and certification services. We support critical decisions made by our customers through the application of rigorous science and the knowledge and expertise of our over 2200 employees. Our annual Corporate Responsibility Report outlines our efforts to continually improve our business performance and practices. Its publication is an industry first and an integral part of our commitment to success with responsibility. LinkedIn
Maxxam Analytics Maxxam is the Canadian market leader in analytical services and solutions to the energy, environmental, food and DNA industries and a member of the Bureau Veritas Group of companies – a world leader in testing, inspection and certification services. We support critical decisions made by our customers through the application of rigorous science and the knowledge and expertise of our over 2200 employees. Our annual Corporate Responsibility Report outlines our efforts to continually improve our business performance and practices. Its publication is an industry first and an integral part of our commitment to success with responsibility.
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