Accelerated storage

Davies, O. L., and Hudson, H. E., Stability of Drugs—Accelerated Storage Tests, Chapter 21B in Statistics in the Pharmaceutical Industry, C. R. Buncher and J.-Y. Tsay, Eds., Marcel Dekker, 1994. 

For accelerated studies, a minimum of three time points (including the initial and final time points, 0 and 6 months) of at least 6 months is recommended. If a significant change is observed at the accelerated storage condition, testing at the intermediate storage condition for a minimum of four time points (including the initial and final time points) from a 12-month study is recommended. 

If significant change occurs between 3 and 6 months testing at the accelerated storage condition, the proposed retest period should be based on the real-time data available at the long-term storage condition (Table 2.2). If... 

Formation in double-base propints during accelerated storage) 9) W.A. Schroeder et al, AnalChem 23, 1740(1951) CA 46, 5444... 

A typical feed composition was 1000 g capsul, 2334 g deionized water and 200 g orange oil. The finished powders were stored in amber bottles at -25prior to accelerated storage study and relevant analyses. Particle Size Analysis. To ascertain the effect of atomizer voltage on the particle size, the particle size distributions of three powders were first determined. The Microtrac laser light particle size analyzer (Medallion Laboratories, Minneapolis, MN) was used in this study. The volume percent data over particle diameter ranging 2.8 p. to 176 jii was recorded. Mean value of the volume percent distribution and calculated surface area were also obtained. 

Accelerated Storage Study. Each of the three powders (20g) were transferred to amber glass bottles (2 oz.). These bottles were stored in a constant temperature oven (45 + 1 C). Samples (Ig) were taken after 0, 3,... 

The oil stability index (OSI) method provides results in a matter of hours instead of months (required for studies done at ambient temperatures). These OSI results are useful as comparative measures of oxidative stability, i.e., to determine the effect of a treatment or antioxidant compared to a control sample. Meaningful predictions of the actual shelf lives of specific commodities require that such shelf life studies be performed at ambient conditions. If only accelerated tests are to be performed, two or more tests based on different principles of lipid oxidation measurement should be conducted the effect of accelerated storage temperature should also be investigated. 

Lab and factory manufacturing Accelerated storage conditions Ambient environment as well as formulation Plasma... 

Malleshi et al. (1989) noted that, under ambient conditions (27 °C and 65%RH), the shelf life of the malted ragi and green gram weaning food was 3 months and was reduced to 2 months under accelerated storage... 

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