Government Requirements:
Stability Testing for New Drug Formulations
•  An account of trials to establish stability on storage under Australian conditions
•  Details of containers used in stability trials
•  Details of conditions of storage in trials
•  Methods of testing
    -  includes precision and specificity for estimating active        ingredients and degradation products
•  Results of stability trials on dosage form as proposed for the  Australian market
-   including: formation of specific degradation products
                        changes in physical characteristics
                        loss of preservative efficacy