Real-time stability studies are the “gold standard” in determining expiration date and shelf life. In this approach, the product is stored at recommended storage conditions and monitored until it fails the specification. Therefore, the duration of the test period should be long enough to allow sufficient enzyme degradation under storage conditions. As for accelerated testing, the enzymes are stressed at several high (warmer than ambient) temperatures and the active period is recorded. This information is then extrapolated to predict product shelf life. A reasonable statistical treatment in accelerated stability projections requires that at least four stress temperature be used. In addition, more nearly accurate stability projections are obtained when denaturing stress temperature are avoided.
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