Stability Testing

 

CentraLabS are fully Good Manufacturing Practice (GMP) and ICH compliant and our world-class expertise provide the following:

  • Method development - including stability indicating assays
  • Method validation - ICH Q2A, Q2B
  • Compound characterisation
  • Stability trials for formulation development
  • Identification of impurities and degradation products (following stressing studies)- ICH Q3A, Q3B
  • Photostability testing - ICH Q1B
  • Stability trials for clinical trials applications (CTA)
  • Stability trials for product licence applications (NDA/MAA) - ICH Q1A, Q5C
  • QC release testing (including QP certification) for clinical trials and marketed products
  • Post-approval stability trials
  • New dosage form stability trials - ICH Q1C
  • Analytical support for process and cleaning validation
 

 

 

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