The purpose of stability testing is to provide evidence on how the quality of drug substance (or drug product) varies in time under the influence of several environmental factors, such as temperature, humidity, and light.

Selvita offers comprehensive set of services related to stability studies for different formulations, drug substances or drug products in different dosage forms. The scope of stability studies includes stability study protocol preparation, study monitoring, complete analytical testing necessary for a particular drug and continuous summary reporting of stability results.

Stability testing complied with ICH requirements available on site is as follows:

  • Long term stability:
    • 25°C ± 2°C/60% RH ± 5% RH
    • 30°C ± 2°C/65% RH ± 5% RH
    • 30°C ± 2°C/75% RH ± 5% RH
    • refrigerator 5°C ± 3°C
    • freezer – 20°C ± 5°C
    • below -20°C: -80°C
  • Intermediate term stability:
    • 30°C ± 2°C/65% RH ± 5% RH
  • Accelerated stability testing:
    • 40°C ± 2°C/75% RH ± 5% RH

Upon Client’s request, stability studies conditions can be customized by Binder stability chambers qualification against alternate temperature and humidity, in line with other climatic zones.

  • Photostability testing
    • fluorescent lamp and ultraviolet (UV)
  • Forced degradation studies
    • Hydrolysis (exposure to acidic, alkaline)
    • Oxidation (oxidizing stresses)
    • Photolytic (exposure to light)
    • Thermal (exposure to heat)
  • Other (freeze/thaw, in-use stability, open-pot stability)