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Service Portfolio

Method Development – Method Lifecycle Management (MLCM)

  • Method development in a QbD framework (Stage 1)
  • Robustness testing (Stage 1&2)
  • Validation studies (Stage 2)
  • Stress, stability and release testing (Stage 3)

  • Troubleshooting of existing methods (in all Stages)
  • Robustness testing of existing LC methods
Visualisation Methods Life Cycle Management

Representation as a progression diagram


  • Analytical Instrument Qualification (AIQ)
  • Advanced preparation for GMP inspection/audits
  • Risk assessments
  • Laboratory instruments sales/purchase


  • Training for HPLC, UPLC, and UPC technologies (theory and praxis)
  • Quality by Design in analytical method development and sample preparation
  • LC Troubleshooting

Impurity profiling

  • Nitrosamine screening using our validated and published SFC-MS/MS method
  • Nitrosamine detection using LC-MS/MS with APCI ion source
  • Extractables and leachables studies
  • Stress testing with mass balance consideration
  • Photo stability testing
  • ICH short- and long-term stability studies

Analytical capabitities

  • Chromatographic systems controlled by Empower 3 (Waters)
    • HPLC (Waters Alliance)
    • UPLC (Waters Acquity)
    • UHPLC (Waters Acquity ARC)
    • bio-inert SFC (Waters Acquity UPC²)
    • IC and GC
  • Comprehensive sample preparation equipment
  • Pharmaceutical Technology equipment
    • Incl. Dissolution tester
    • sub-visible particle (SVP) analyzer
  • Stability and Photo-stability chambers

Detection capabitities

  • Photo diode array UV detection (PDA)
  • Fluorescence detection (FLD)
  • Refractive index detection (RID)
  • Evaporative light scattering (ELSD)
  • Single-Mass detection (QDa)
  • Tandem-Mass detection (TQD) with ESI and APCI ion source
  • Charged-Aerosol detection (CAD)
  • Chemiluminescence nitrogen (CLND)
  • Conductivity detection
  • Electrochemical detection (ECD)