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  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica

Pharmaceutical analyses

 

Stability studies

We perform ICH stability studies on drug substance and /or dosage form. Studies are conducted according to the Stability Study Protocols and fully under GMP conditions. Stability study projects are the most commonly performed service in the Pharmaceutical Analyses Department/QC. Since 1999, more that 200 stability study projects have been conducted.

Our services for stability studies cover:

  • Stability Study Protocols
  • Stability conditions
    • 2-8°C
    • 25°C/60% RH, 2 boxes total area 30m2
    • 30°C/65% RH, box area 12m2
    • 30°C/75% RH, box area 12m2
    • 40°C/75% RH, 2 boxes area total 12m2
    • Light exposure
    • transportation studies 
  • Intermediate and Summary reports of stability results