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)
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, LC-ToF, 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.

OUR APPROACH

Before the initiation of a project, it is of paramount importance to align the analytical approach in an Extractables / Leachables study with the customer needs, the regulatory requirements and the material specifics.
Our specialized team of project managers will assist you in all steps of the project (study design, study initiation, follow-up of running projects, interpretation of data and assistance in regulatory guidance).

QUALITY

Toxikon Europe is ISO 17025 certified. This ISO 17025 standard, �General requirements for the competence of testing and calibration Laboratories�, is implemented to demonstrate and operate a management system, which is technically competent, and able to generate technically valid results. In general, the quality objective with respect to our testing services to a broad range of customers with different requirements, can be given as �conformance to customer requirements, providing accurate results, combined with an on-time delivery, on a consistent basis�.
In addition, Toxikon Europe is an FDA registered laboratory (FDA Registration N� 3005742674) and is offering GMP compliant testing programs for the Pharmaceutical Industry.

If you would be interested to find out more about our services and testing programmes, please feel free to contact us at info@toxikon.be or call us at ++32 (0)16 400.484.