Chemical Impurity Testing And Analysis

Chemical impurity analysis is the scientific process of identifying and isolating unknown materials in chemicals, polymers, packaging, pharmaceuticals, finished products, in order to identify them. This type of testing may be required as part of a chemical or products registration. Samples and products may require special extraction and leach procedures such as those listed in ISO 10993‐12 under part 12: ‘Sample preparation’. Leeder Analytical is able to carry out these specific tests to meet your project needs.

There are typically three groups of impurities which are evaluated and identified when conducting impurity analysis:

  • Organic impurities
  • Inorganic impurities
  • Residual solvents

Sources of these impurities can vary. They can be by-products of manufacturing, contamination from other materials, and possibly the storage of the materials themself.

Chemical impurity testing is incredibly important – as impurities and irregularities can cause massive disruption for organisations through product recalls and delayed manufacturing timelines. When it comes to the medial industry in particular, chemical impurities can be very important for a company’s product and image. As such, having an impurity identified could be critical.

Chemical impurity testing is often a complex task and requires an expert team that has the skills and experience to not only test but analyse and identify the compounds found – plus providing detailed explanations of the likely sources of the impurities.

At Leeder Analytical, or expert team performs extractable and leachate tests and studies to quantitate any potential impurities that can original from packaging, processing equipment or other sources. 

Material Identification

Utilising our professional experience alongside state-of-the-art laboratory analytical equipment the team at Leeder Analytical are able to identify impurities and unknown materials found in your products and samples.

Who we work with?

Our NATA accredited laboratory conducts impurity testing and material identification for food manufacturers, pharmaceutical manufacturers, engineers, scientists, consultants, packaging specialists, regulators and government bodies.

These professionals choose to work with Leeder Analytical because we offer reliable and accurate testing, as well as extract key insights from the scientific findings.

Some of the organisations we’ve worked with includes:

They choose Leeder Analytical because they’re able to trust in the speed, effectiveness and efficiency of our processes, and importantly the accuracy of our results and interpretations.

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Chemical Impurity Analysis Methodology

At Leeder Analytical, we utilise a wide range of tests including Gas Chromatograph / Mass Spectroscopy / Mass Spectroscopy (GC/MS/MS) and Ultra high-performance Liquid chromatography- Mass Spectroscopy / Mass Spectroscopy (UHPLC/MS/MS) to isolate and produce the most reliable impurity test results possible.

Our testing methodology has been developed, accredited and validated to detect irregularities at ultra-low, trace levels using our purpose-built laboratory and state of the art instruments.

Other testings on offer include x-ray fluorescence (XRF), x-ray diffraction (XRD) and scanning electron microscopy with energy dispersive x-ray analysis (SEM-EDAX).


For a free quote or a discussion on how Leeder Analytical can assist you with analytical testing services please contact us today via the form below

To talk to our team regarding testing services, please call 03 9481 4167