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.
