Extractables and Leachables Services

Toxikon Europe offers a comprehensive approach towards Extractables / Leachables testing for the pharmaceutical industry. Our approach combines a technical and analytical expertise, polymer knowledge, understanding of regulatory requirements, all combined in a tailored approach to our customers.

 

ANALYTICAL EXPERTISE

Toxikon Europe is equiped with the state-of-the-art analytical technology, such as:

  • Headspace coupled to gas chromatography with a mass spectral detection (HS-GC/MS)
  • Gas chromatography with a mass spectral detection (GC/MS)
  • Programmable temperature vaporizer gas chromatography with a mass spectral detection (PTV-GC/MS)
  • Liquid chromatography with a diode array detection combined with mass spectral detection (HPLC-UV/MS)
  • Liquid chromatography with multiple order mass spectral detection (LC/MS/MS)
  • Inductively coupled plasma with an optical emission detection (ICP-OES)
  • Ion Chromatography (IC)
  • Graphite Furnace - Atomic Absorption Spectroscopy (GF-AAS)
  • Infrared spectrophotometry (FTIR)
  • UV/VIS- Spectrophotometry
  • Total organic carbon analyzer(TOC)
  • .........

 

All instruments are dedicated to – and the methods are optimized for – extractables and leachables testing for the pharmaceutical industry, which requires all analytical equipment to be fully qualified (IQ/OQ/PQ).

In addition to the standard Extractables and Leachables testing programmes, Toxikon Europe can offer its assistance in the elucidation of structural information for critical compounds, using GC-ToF-MS, LC/MS-Orbitrap, LC-ToF-MS, FT-MS or NMR.

Because of the high importance of a unique identification of material impurities during extractable and leachable studies, Toxikon Europe has built up a “library” of more than 1000 reference standards, relevant to trace impurity testing in polymer and rubbers. These reference standards are used to confirm the identity (via retention time or mass spectral confirmation) of the extractable / leachable compounds.

Toxikon Europe also offers capacity for storage under controlled temperature and humidity for a variety of different storage conditions, this to support the stability programme for leachable studies. The climatic chambers are fully qualified and are monitored via a central data logging system.

Our Analytical expert team has a broad experience in method development and validation of long list of trace impurities (leachables) in a variety of pharmaceutical matrices, ranging from aqueous buffered saline solutions, over more complex pharmaceutical formulations (e.g. containing Polysorbate, PEG, protein solutions) and even very complex matrices (e.g. oily solutions, syrups, ointments).

 

POLYMER KNOWLEDGE & REGULATORY GUIDELINES

Although E/L-trace analysis testing often poses significant challenges to the analytical development team and therefore requires a high level of analytical expertise, it is of equal importance to have a thorough understanding of polymer and rubber knowledge, together with a profound knowledge on the global regulatory requirements per type of application. This combined expertise is of high importance in both the development phase of a testing strategy for a specific E/L project, as well as to understand and interpret the obtained analytical results and to assess these data from a regulatory point of view.


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Contact:


Dr. Piet Christiaens
Scientific Director

piet.christiaens@toxikon.be

Extractables and Leachables Services