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Stability studies

Our services

  • Protocol design and optimisation
  • Development and validation of stability-indicating methods
  • Identification of degradation products
  • Compatibility studies
    • DS and excipients
    • Leachables and extractables
    • Sorption, migration, degradation of DS
  • Stability studies
    • Preliminary assessment and short-term
    • Forced degradation studies
    • Following ICH guidelines
    • Photostability (in controlled conditions)
    • In-use stability and freeze-thaw cycling
  • To support
    • Clinical trials application (INDA/IMPD)
    • Product licence application (NDA/BLA/MAA)
    • Post-approval monitoring (variations, commitment batches)
  • Preservative testing
  • Container Closure System Integrity
  • Sample management and storage

Storage

  • 150 m3 capacity, 7 walk-in chambers
  • Cabinets, refrigerators, freezers including ultralow temperature, liquid nitrogen vapour phase
  • All ICH conditions available
  • Customised conditions for specific requests
CONDITIONS
ICH CONDITIONS OTHER CONDITIONS ULTRA-LOW CONDITIONS
     
-20°C ± 5°C -30°C ± 5°C -60°C ± 10°C
5°C ± 3°C 15°C ± 2°C -70°C ± 10°C
25 ± 2°C/ 40 ± 5% RH 20°C ± 2°C Vapour phase nitrogen (-196°C)
25 ± 2°C/ 60 ± 5% RH 30°C/ <40%RH  
30 ± 2°C/ 65 ± 5% RH 50°C/ <40%RH  
40 ± 2°C/ not greater than 25% RH 60°C/ <40%RH  
40 ± 2°C/75 ± 5% RH 22,5 ± 2,5°C/1000 lux ± 400 lux  
30 ± 2°C/35 ± 5% RH    
30 ± 2°C/75 ± 5% RH    

 

All matrices

  • Drug substances
  • Drug products
  • Starting materials
  • Excipients
  • Packaging materials
  • (Pre) Clinical batches

Analysis and reporting

  • All laboratories on one site
  • Analyses carried out according to pre-defined protocols
  • At each time point, a report presenting your data in the required format

Communication

  • Highly experienced scientific team advises you at every stage
  • A dedicated team in close contact with you, dealing with your project efficiently and helping you to meet your objectives

Quality Assurance

  • Full compliance with cGMP (FDA inspected)
  • Computerised sample flow management
  • 24/7 computerised monitoring of conditions
  • Back-up storage facilities
  • Back-up electricity generators
  • In-house maintenance and qualification teams
  • Secure site (restricted access, alarm systems, etc.)


You can download the brochure
stability-studies-quality-assistance

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