Shelf-life determinations

Tinplate that meets the rigid specifications imposed by these controls is sometimes supplied as special quality material and undoubtedly can give improved shelf-life, particularly with citrus fruits. The A.T.C. value has probably more effect on shelf-life determined by hydrogen swell than any other factor. 

This chapter will describe the use of nuclear magnetic resonance and magnetic resonance imaging to characterize the quality attributes of foods and for use in process optimization, shelf-life determination and component migration. 

The recommended disinfectant solution must be able to establish a six-log reduction of each of the inoculated microorganisms within 5 minutes. For shelf-life determination, perform membrane hltration technique to conform to the manufacturer shelf life data. 

Evaluation of Stability Data and Shelf Life Determination... 

EVALUATION OF STABILITY DATA AND SHELF LIFE DETERMINATION... 

The documents identified as quality records are kept secured according to the shelf life determined and are easily retrievable. 

The samples (ca. 2500 g for each sample) were spray dried in a Niro Utility drier with the inlet temperature at 200 C and outlet at 100 C. The drier temperatures were allowed to stabilize before samples were collected for analysis. The dried samples were analyzed for total oil, surface oil, moisture, emulsion size and emulsion stability. Samples were also stored at an elevated temperature for shelf-life determination. Sensory analysis of rehydrated powder from the coarse and Microfluidized emulsions was performed to determine if differences in emulsion size affects the perceived flavor intensity. 

Appropriate storage conditions and shelf-life determination... 

Shelf life determination at various storage temperatures. 

Tsong Y, Chen WJ, Lin TY, Chen CW. Shelf life determination based on equivalence assessment. J Biopharm Stat 2003 13 431-449. 

Thermal stability studies on pharmaceutical formulations have been formalized for many years. Specific protocols have been developed to provide data from which a shelf-life determination can be made (Carstensen, 1995). Thus, procedures followed in one laboratory are readily reproduced in another, and shelf-life is a consistent estimation for the product, independent of the laboratory in which the data were gathered. In thermal stability studies, the principal consideration is how long the drug substance or formulation is exposed to a particular temperature. The nature of the apparatus to be used is not important as long as the temperature of the sample is uniform. Thus, the sample may be contained in a flask, bottle, or tube, or held in a water thermostat or an air incubator — whatever is most convenient for the study. Also, the concentration of the drug studied is not crucial because a thermal degradation usually proceeds by first-order kinetics for which the half-life is independent of the starting concentration. 

In the study of thermal stability, accelerated testing in the form of elevated temperatures has been used by many pharmaceutical companies to minimize time involved in the testing process. This procedure is only valid for simple formulations in which the single major ingredient is broken down by a thermal reaction. In practice, regulatory authorities demand that a shelf-life determined by extrapolation of accelerated test data should be supported by actual stability data obtained by normal temperature storage (Carstensen, 1995). This is because degradation of a product by microbial contamination may well be inhibited at elevated temperatures. 

Labreche S., Bazzo S., Cade S., and Chanie E., Shelf life determination by electronic nose Application to milk, Sens. Actuators B, 106(1), 199, 2005. 

In the determination of the shelf-life, one generally measures a value that changes with time. From a plot of the changing value vs. time, it is possible to estimate (with interpolation) the time when the critical parameter value is attained. The change in the value with time may not be linear, yet there are generally insufficient time points in a stability study (due to resource limitations) to explicitly determine the functional form of the changes with respect to time. Even if the linear approximation is valid, the uncertainty needs to reflect the confidence intervals for the measured values. As an example, in Fig. 6.5, a set of measurements are shown as a function of time. As can be seen in the example, the final shelf-life (i.e., the time it takes for the degradant in this example to reach a level of 0.2% of the API) will have a confidence interval (error bar) that reflects the confidence intervals from the measurements. To improve the precision of the shelf-life determination in this case, one needs to... 

TG has been used to examine starting materials, intermediates and finished products, as well as to characterize the interactions with excipients used in drug formulation [26, 27, 28]. Thermal stability of the formulated drug is important for shelf-life determinations as well as for understanding of interactions with excipients. Different combinations of the drug formulations were examined to determine which components were involved in decreasing the thermal stability of the primary component of the drug formulation. 

With respect to organic compounds, those that are precursors to pharmaceuticals have attracted increasing interest from the viewpoint of their thermal properties, and TA techniques are used frequently in quality control procedures for such compounds. A wide variety of common and less common pharmaceuticals have also been investigated using a variety of thermal methods - mainly BSC and mainly in the context of purity determination. There is also potential for using TA techniques to identify pharmaceutical activity and for shelf-life determinations. 

A mass intensity list was obtained for each sample by averaging the masses between 100 s and 500 s. The mass intensities were then normalized by dividing by the intensity of the major mass peak for the chlorobenzene internal standard m/z 112). For PLS calculations, these normalized mass ratios from m/z 50 to m/z 150 were used as independent variables, and the shelf life determined by sensory analysis was used as the dependent variable. Internal standard normaliza-... 

Table 2 compares actual shelf life (determined by sensory evaluation) to predicted shelf life for the 20 PLS Model Validation Subset samples for reduced-fat milk. On average, the SPME-MS-MVA PLS model for reduced-fat milk predicted the shelf life with an accuracy of 0.62 days, with a correlation coefficient of 0.9801 and a range of -0.7 to 2.8 days. 

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