The purpose of stability testing is to provide evidence of how the quality of an API or FPP varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. The stability testing program also includes the study of product-related factors that influence its quality, for example, interaction of the API with excipients, container-closure systems and packaging materials. In Fixed-Dose Combinations (FDCs) the interaction between two or more APIs also has to be considered.
As a result of stability testing, a retest period for the API (in exceptional cases, for example, for unstable APIs, a shelf life is given) or a shelf life for the FPP can be established and storage conditions can be recommended. An API can be considered unstable (under the conditions studied, in a particular type of packaging, etc.) when a significant change is observed.
Stability studies are highly scrutinized by regulatory agencies. Companies must be able to prove the validity of their data. Automated solutions provide the ability to produce the necessary documentation in real-time to satisfy auditors. Systems like Nova-Stability helps companies maintain regulatory compliance while reducing risk to the patient.
Labwise® XD Stability is a powerful platform with embedded quality, compliance, electronic lab notebook (ELN) creating a comprehensive solution assuring compliance with regulatory guidelines on a global level. It accommodates all types of stability studies.s
Xybion’s statistical package handles all types of statistical models ensuring an accurate shelf-life evaluation.
- Regression analysis
- Analysis of variance (ANOVA tables)
- Analysis of covariance (ANACOVA tables)
- Data pooling (p-value)
- Arrhenius equations (regression and estimation models)
Using the XD platform-based Labwise XD Stability module produces an accurate determination of the shelf-life, maintain regulatory compliance decrease your time to market.