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Pharmaceutical manufacturers need to determine the extractables and leachable profile of their packaging ​system components. This is to ensure that the product quality and the safety of the patients are maintained. Our ​team of experts can provide you with analytical expertise to determine the most appropriate safety thresholds, ​extraction and analysis techniques. Extraction Techniques for Extractables & Leachable

We offer extraction techniques such as

We offer extraction techniques such as

• Reflux,
  
• Soxhlet
  
• Sonication.
  

Our analytical techniques include semi-quantitative screening by LC/MS, GC/MS, LC/UV.

• Semi-quantitative screening for both volatile and semi-volatile organic compounds:
  
• Use of GC/MS instrumentation with direct injection sample introduction and electron impact ionization
  
• Use of GC/MS instrumentation with headspace sample introduction and electron impact ionization
  
• For extractables compounds detected by GC/MS analysis, we utilize NIST2011 database to assist in ​identification.
  
• Semi-quantitative screening for non-volatile organic compounds:
  
• Analysis using LC/HRMS, HPLC/UPLC MS (electrospray and atmospheric pressure chemical ionization) and ​LC/UV-vis.
  
• Specific compound workflow identification by means of LC-HRMS analysis and Compound Discoverer ​software.
  

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