Accelerated Predictive Stability (APS)

APS is an accelerated ageing process for small pharmaceutical molecules providing faster predictions for drug substance and drug product shelf-life.

3 Stage Process

  1. Ageing – Test material exposed to a range of stress conditions (T/rh)
  2. Analysis – Aged test material analysed using Stability Indicating Method (e.g. for Degradants or potency)
  3. Model Building – Stability Predictive Model built using data from ageing and analysis as inputs to modelling software

Test Materials

APS has been used successfully on most product types:

  • Solids (capsules, tablets, powders, lyophilised & more)
  • Drug Substance and Drug Product
  • Liquids
  • Peptides and oligonucleotides
  • Medical Devices


  • Quicker Formulation Development (using tiered approach)
  • Choose optimum packaging for different climatic zones
  • Choose tablet count, bottle size and desiccant to meet shelf-life required
  • Choose packaging without the need for package screening studies
  • Packaging Selection (quicker decisions and cost effectiveness):
  • Determine effect of excursion on stability (e.g. during shipment)
  • Assist during cost modelling (e.g. package choices for different climatic zones)
  • Assess effects of process or material change on stability (manufacturing process, ingredients, supplier, formulation change)
  • APS data has been accepted by regulatory authorities in many countries

    Cuspor provides Temperature and Humidity calibration services using accredited transfer standards in the range 10oC to 85oC and 0-90%rh. We specialise in the calibration of Hygrochron DS1923-F5 loggers.

    Typical measurements of the uncertainty values are detailed in the table below: