With more than 25 years as a high-quality analytics provider, we have built a team of enthusiastic scientists and support technicians that excel in finding rapid solutions to keep your projects on-track. 

Analytical Chemistry

  • Professional expertise and regulatory qualifications necessary to perform analytical testing of raw materials, bulk materials and finished products 
  • Well equipped, state-of-the-art laboratories offering comprehensive testing services according to the pharmacopoeia (e.g. EP, USP, BP, JP) and customer specifications 
  • Comprehensive services for QP release testing 
  • Assay and chemical tests 
  • Spectroscopy (UV/VIS, IR, AAS) 
  • Chromatographic tests (HPLC/ UHPLC, GC, TLC) 
  • Physical & physico-chemical determinations
    • pH  
    • Viscosity  
    • Melting Point  
    • Particle Size  
    • Loss on drying  
    • Limit tests  
    • Heavy Metals  
    • Ash  
    • Residual Solvents  
    • Volatile organic compounds (VOC)  
    • Organic volatile impurities (OVI) 

Pharmaceutical technical procedures:

  • Disintegration
  • Dissolution
  • Hardness
  • Friability

Method development:

  • Assay testing
  • Dissolution
  • HPLC
  • GC
  • Stability indicating methods

Method validation:

  • Accuracy
  • Precision
  • Specificity
  • Detection limit
  • Quantitation limit
  • Linearity
  • Range
  • Robustness
  • System suitability test

Stability storage and testing

  • Study design to storage, monitoring, analytical testing and documentation
  • Complete bandwidth of storage conditions in numerous climatic walk-in chambers and climatic cabinets with a total storage capacity of approximately 400 m3
  • Refrigerators and freezers available for storage at lower temperatures and chambers for flexible conditions on client's request. All storage chambers are fully controlled with 24h/7d monitoring and alert system

Services:

  • Support in designing studies for real time, stress tests and photo stability studies
  • Development and validation of stability indicating methods
  • Examination of stability-relevant parameters
  • Storage and management of stability samples
  • Interim reports for every testing period
  • Comprehensive final report

Climatic Zones include (according to ICH Guidelines)

  • 21°C / 45% r.h.
  • 25°C / 60% r.h.
  • 25°C / 85% r.h.
  • 30°C / 65% r.h.
  • 30°C / 70% r.h.
  • 30°C / 75% r.h.
  • 40°C / 75% r.h.
  • 5°C, -20°C and -80°C