Accelerated stability studies

In thermal stability studies, accelerated testing at elevated temperatures is used to minimize the time needed to assess the thermal stability of the substance/ product. From the Arrhenius plot, one can predict the shelf life of the product at a proposed storage temperature. 

Spin system, 157, 159 Splitting, Zeeman, 154 Stability study, accelerated, 260 Standard potential, 254, 359 Standard reaction, 315 Standard state, 253 selection of, 208 Stationary-state hypothesis, 101 Statistical analysis, 40 Statistical analysis of solvent effects,... 

As described in ICH QIA, in addition to long-term stability studies, accelerated studies can be used to assess longer term chemical effects at non-accelerated conditions, and to evaluate the effect of short-term excursions outside the label storage conditions such as might occur during shipping. A substance or product that is stable at accelerated conditions, for example at 40°C/75% RH for 6 months, would not be degraded by temperature fluctuations above 30°C nor by short-term excursions. 

REDDY SASTRY c V, RUKMINI c (1997) Stability studies on stabilized rice bran under accelerated conditions for twelve weeks. (RiceX Company Report). 

The plastic bottle and dispensing tip is made of low-density polyethylene (LDPE) resin, which provides the necessary flexibility and inertness. Because these components are in contact with the product during its shelf life, they must be carefully chosen and tested for their suitability for ophthalmic use. In addition to stability studies on the product in the container over a range of normal and accelerated temperatures, the plastic resins must pass the USP biological and chemical tests for... 

Because of the multiple degradation pathways that may take place at elevated temperature, protein stability monitoring data may not conform to the Arrhenius relationship, and the maximum temperature selected for accelerated stability studies must be carefully selected. Gu et al. [32] described the different mechanisms of inactivation of interleukin-1 (3 (IL-1 (3) in solution above and below 39°C. In this example, the multiple mechanisms precluded the prediction of formulation shelf life from accelerated temperature data. In contrast, by working at 40° C and lower, Perlman and Nguyen [33] were able to successfully extrapolate data from stability studies of tissue plasminogen activator down to 5°C. 

KA Jandik, D Kruep, M Cartier, RJ Linhardt. Accelerated heparin stability studies. J Pharm Sci 85 45-51, 1996. 

If the submission includes data from stability studies on at least three production batches, a commitment should be made to continue the long-term studies through the proposed shelf life and the accelerated studies for 6 months. 

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