Chemical Impurity 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.
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.
For a free quote or a discussion on how Leeder Analytical can assist you with your testing and analysis requirements please contact us today via the form below, or on 03 9481 4167.