Shelf-life stability assessment

O Mahony F.C., O Riordan T.C., Papkovskaia N., Ogurtsov V.I., Kerry J.P., Papkovsky D.B., Assessment of oxygen levels in convenience-style muscle-based sous vide products through optical means and impact on shelf-life stability. Packaging Technol. Set, 2004 17 (4) 225-234. 

Rapid Method for Assessing Shelf-Life Stability.16... 

RAPID METHOD FOR ASSESSING SHELF-LIFE STABILITY... 

The use of enantiomers as additional markers for taxonomic characterization of aromatic plants may be very helpful. The differences in the enantiomeric distribution of trans- and cis- sabinene hydrates in two Origanum species enable the species to be distinguished in spite of their similar essential oil compositions. A further study on the natural variation of the enantiomeric composition within a wild population may be carried out in order to examine the stability in a taxon (including the possible presence of chemotypes). The enantiomeric ratio of essential oil components is a reliable parameter for assessing quality because it may be indicative of adulteration, contamination, aging, shelf life, technological process and the botanical source of a specific chiral compound. ... 

Integrity over the product shelf life. The following testing is performed to assess the microbiological characteristics over the stability of the product. 

Shelf Life This term refers to the expected duration of the functional stability of biological substances, including immunochemicals, and most commonly is assessed by experimental tests, statistical work and observation. Within the user s laboratory, periodical comparisons of the working solution with aliquots kept frozen at -20 °C is recommended. The shelf life is terminated by an Expiration Date. 

Great effort should be taken to stabilize a formulation in such a way that the shelf life becomes independent of the storage conditions. The photostability of drugs and excipients should be evaluated at the formulation development stage in order to assess the effects of packaging on the stability of the final product. Molsidomine tablet preparations in inadequate primary containers (blister) without secondary containers when exposed to irradiation may produce morpholine. These results illustrate the importance of packaging for the stability of molsidomine [19]. 

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. 

Commercialization of ODTs have to go through the final evaluation of long-term stability of the tablet matrix and packaging components per International Conference on Harmonisation guidelines. As the majority of ODT dosage forms on the market are sensitive to moisture, evaluation of moisture vapor transmission rate is an important parameter for assessing the shelf life of the product. 

Before a bracketing design is applied, its effect on the shelf life estimation should be assessed. If the stability of the extremes is shown to be different, the intermediates should be considered no more stable than the least stable extreme (i.e the shelf life for the intermediates should not exceed that for the least stable extreme). 

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