Services
APS is an accelerated ageing process for small pharmaceutical molecules providing faster predictions for drug substance and drug product shelf-life.
3 Stage Process
- Ageing – Test material exposed to a range of stress conditions (T/rh)
- Analysis – Aged test material analysed using Stability Indicating Method (e.g. for Degradants or potency)
- 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
Benefits
- 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:
