Nitto Avecia Pharma Services
Residual Solvents Testing

Residual Solvents

Assure Compliance Now With Avecia Pharma's Cost Effective Identification and Quantification of Impurities

Avecia Pharma 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.

Avecia Pharma'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

Avecia Pharma'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

Avecia Pharma 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 Avecia Pharma'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

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