| Extractable and Leachable Analysis |
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This area of growing regulatory significance provides many challenges in the analysis of inhalation and injectable drug products.
Our vast experience in the analysis of container / closure and packaging systems allows us to understand the challenges you face and to assist in the characterisation and quantitation of the most complex extractable profiles.
Using a combination of liquid and gas chromatography coupled to high-performance mass spectrometry we are able to provide structural information on a large range of extractable materials. The identification of ‘unknowns’ is our speciality. |
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| Typical Materials Characterised: |
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• Plastic Components
• Coatings
• Elastomers
• Anti-oxidants
• Accelerants
• Raw materials and additives |
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| A Typical Process: |
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• Samples extracted in appropriate solvents
• Standard and blank analyses obtained
• Sample extractable profiles obtained using GC-MS and LC-MS (+ve and –ve ion)
• Other supporting analyses undertaken
• Unknown materials characterised through spectral interpretation |
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| Click here for a Typical Process |