Irvine Pharmaceutical Services
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  A Pharmaceutical Development Company

Residual Solvents Testing

 
ASSURE COMPLIANCE NOW WITH IRVINE’S COST EFFECTIVE IDENTIFICATION AND QUANTIFICATION OF IMPURITIES
 

Irvine provides expert, rapid analysis of all three classes of residual solvents. Our USP/ICH compliant, state-of-the-art laboratory and experienced team of scientists allow you to manage the large number of methods that may be involved in identification and quantification of impurities, including residual solvents.

 
Irvine’s Expertise Encompasses:
  • Strict compliance of ICH guidelines
  • Detection, profiling and control support of residual solvents in drug substances, excipients, and Drug products
  • Water-soluble/Water-insoluble raw materials and APIs
  • Screening for potential interference
  • Screening for identification of unknown peaks
  • Feasibility studies
  • Validation of analytical methods
  • Assistance in regulatory reporting
  • Comprehensive and accurate reports
Irvine’s Multiple Points of Interaction:
  • Joint review of DMF/physico-chemical properties of the API
  • Meetings to ensure appropriate
  • Technology GC-FID or GC/MS
  • Limits, e.g., TDI
  • Procedure for method transfer/validation
  • Process prescreening, routine testing, API qualification
Faster Analysis, Enhanced Sensitivity

Irvine remains committed to ongoing, effective upgrades in software and instrumentation so you can benefit from faster, more selective and sensitive testing. Currently, you benefit from Irvine's state-of-the-art equipment that reduces the number of separation phases.

  • Agilent GC/MS with Head Space Analyzer (6890N GC System, 5975 inert XL Mass-Selective Detector, G1701DA ChemStation software.)
  • Combi PAL CTC Autosampler System for headspace and liquid injection
 
REQUEST A PROPOSAL TODAY!