iStability® is ScienTek Software’s next generation stability management software. Built from the ground up while leveraging the experience we had creating, evolving, and supporting STABILITY SYSTEM, iStability is the new gold standard. Please visit www.iStability.com for more information and contact us there if you have further interest.

Statistical Data Analysis in STABILITY SYSTEM

STABILITY SYSTEM supports FDA/ICH recommended analysis methods out of the box; no need to acquire another module or statistical package, as our analysis tools are fully validated and have been used by industry professionals for over 30 years. Furthermore, no statistician will be required to understand our analysis reports.
Expiry Dating Calculation
Shelf life prediction: Calculate the expiry dating period different kinetic orders. Graphs are beautiful and effortless to generate. We also support calculation using the pooled mean square error (ICH Q1E, Section B.2.1).
Poolability Determination
Statistically compare data from multiple lots to determine if they can be pooled together. ANCOVA analysis according to ICH Q1E is used.
Arrhenius Treatment
Process accelerated stability data using the Arrhenius equation to estimate expiry dating periods at any storage temperature. A perfect tool for formulators who do not have the luxury of time.
Expiry Dating Simulation
Leverage your data to answer 'What if?' type questions. Calculate expiry dating periods under a variety of simulation conditions, such as determining expiry periods when the QC release data is lower than the acceptable release specification.
Back Calculation Initial Purity
Determine the initial values needed to achieve a targeted expiry dating period, e.g. "what initial values are required to achieve a 36 month expiry dating period based on the existing stability data?". This is a great way to determine the necessary overage.
Import/Export Data
Easily and securely import and export your data in a standard CSV (Comma Separated Values - Excel) format.
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ScienTek Documents on Stability Theory
Excerpts on chemical kinetics and statistical data treatment are provided below. These are great learning materials to enhance your stability skill.
  1. Simple Reactions
  2. Arrhenius Equation
  3. Regression Analysis